Trial Outcomes & Findings for A Study of CIN-107 in Adults With Primary Aldosteronism (NCT NCT04605549)
NCT ID: NCT04605549
Last Updated: 2026-03-03
Results Overview
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
74 weeks
Results posted on
2026-03-03
Participant Flow
The study was conducted from 08 March 2021 to 28 October 2024 at 10 sites in United States
A total of 33 subjects were screened (signed consent), 15 subjects have been randomized into the study. 15 subjects completed Part 1 of the study and 14 subjects entered Part 2 of the study, 2 of those withdrew, therefore 12 subjects completed Part 2 of the study
Participant milestones
| Measure |
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2.
|
|---|---|
|
Part 1 (0 to 12 Weeks)
STARTED
|
15
|
|
Part 1 (0 to 12 Weeks)
COMPLETED
|
15
|
|
Part 1 (0 to 12 Weeks)
NOT COMPLETED
|
0
|
|
Part 2 (12 to 74 Weeks)
STARTED
|
14
|
|
Part 2 (12 to 74 Weeks)
COMPLETED
|
12
|
|
Part 2 (12 to 74 Weeks)
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
CIN-107
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2.
|
|---|---|
|
Part 2 (12 to 74 Weeks)
Adverse Event
|
1
|
|
Part 2 (12 to 74 Weeks)
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study of CIN-107 in Adults With Primary Aldosteronism
Baseline characteristics by cohort
| Measure |
CIN-107
n=15 Participants
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2.
|
|---|---|
|
Age, Continuous
|
53.6 Years
STANDARD_DEVIATION 11.6 • n=41 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
WHITE
|
7 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
4 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
3 Participants
n=41 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=41 Participants
|
|
Region of Enrollment
USA
|
15 Participants
n=41 Participants
|
|
Seated SBP
|
151.5 mmHg
STANDARD_DEVIATION 13.46 • n=41 Participants
|
PRIMARY outcome
Timeframe: 74 weeksPopulation: The Safety Population is defined as all enrolled patients who receive at least one dose of study drug. Due to the small sample size of the study, arms/groups are combined for analysis.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. Adverse events were collected from the beginning of the study until Week 74. Treatment emergent AEs are defined as AEs that newly occur or worsen in severity during the treatment period.
Outcome measures
| Measure |
CIN-107
n=15 Participants
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
|
|---|---|
|
Number of Treatment Emergent Adverse Events
Part 1 before titration (0-Week 4)
|
27 Number of events
|
|
Number of Treatment Emergent Adverse Events
Part 1 after titration (Week 4-Week 12)
|
34 Number of events
|
|
Number of Treatment Emergent Adverse Events
Part 2 (Week 12-Week 74)
|
101 Number of events
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ITT Population is defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
The mean seated SBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean seated SBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Outcome measures
| Measure |
CIN-107
n=15 Participants
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
|
|---|---|
|
Change From Baseline in Mean Seated Systolic Blood Pressure (SBP) in Patients With Primary Aldosteronism
|
-24.9 mmHg
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
The mean DBP was defined as the average of 3 measurements obtained at the clinical site visit. The change from baseline in mean DBP after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Outcome measures
| Measure |
CIN-107
n=15 Participants
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
|
|---|---|
|
Change From Baseline in Mean Diastolic Blood Pressure (DBP) in Patients With Primary Aldosteronism
|
-10.6 mmHg
Standard Deviation 8.95
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
The percentage of patients achieving a mean seated SBP \<140 mmHg and a mean DBP of \<90 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Outcome measures
| Measure |
CIN-107
n=15 Participants
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
|
|---|---|
|
The Percentage of Patients Achieving a Seated BP Response of <140/90 mmHg
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
The percentage of patients achieving a mean seated SBP \<130 mmHg and a mean DBP of \<80 mmHg after 12 weeks of treatment with CIN-107 (Part 1) is calculated.
Outcome measures
| Measure |
CIN-107
n=15 Participants
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
|
|---|---|
|
The Percentage of Patients Achieving a Seated BP Response of <130/80 mmHg
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population defined as all participants enrolled in the study. Due to the small sample size of the study, arms/groups are combined for analysis.
Pharmacodynamic marker response is defined as achieving either: - a plasma aldosterone concentration (PAC) \< 15 ng/dL and a plasma renin activity (PRA) ≥ 0.5 ng/mL/h; or - an ARR \< 15; or - unsuppressed renin activity PRA ≥ 1.0 ng/mL/h
Outcome measures
| Measure |
CIN-107
n=15 Participants
Dosing for CIN-107 at 2, 4, or 8 mg (QD). For Part 1, patients were provided with an initial dose of CIN-107 2 mg once daily (QD). CIN-107 dose could be up-titrated to 4 mg QD at Visit 4 and up to 8 mg at Visit 5 based on tolerability.
For Part 2, the patient continued their dose level subject to titration based on the investigators discretion for part 2. Due to the small sample size and the complex titration procedure, adverse events are summarized overall without separate summaries by dose level.
|
|---|---|
|
The Percentage of Patients Achieving the Pharmacodynamic Marker Response
|
12 Participants
|
Adverse Events
CIN-107 8 mg Part 2
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
CIN-107 2 mg Part 1 - Before Titration
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
CIN-107 2 mg Part 1 - After Titration
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CIN-107 4 mg Part 1 - After Titration
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
CIN-107 8 mg Part 1 - After Titration
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CIN-107 2 mg Part 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CIN-107 4 mg Part 2
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CIN-107 8 mg Part 2
n=7 participants at risk
CIN-107 at 8 mg (QD) dosing anytime during part 2 of the study
|
CIN-107 2 mg Part 1 - Before Titration
n=15 participants at risk
CIN-107 at 2 mg (QD) dosing before titration Visit 4 (Week 4) .
|
CIN-107 2 mg Part 1 - After Titration
n=3 participants at risk
CIN-107 at 2 mg (QD) dosing anytime after titration Week 4 until the end of Part 1.
|
CIN-107 4 mg Part 1 - After Titration
n=13 participants at risk
CIN-107 at 4 mg (QD) dosing anytime after titration Week 4 until the end of Part 1
|
CIN-107 8 mg Part 1 - After Titration
n=8 participants at risk
CIN-107 at 8 mg (QD) dosing anytime after titration Week 8 until the end of Part 1
|
CIN-107 2 mg Part 2
n=4 participants at risk
CIN-107 at 2 mg (QD) dosing anytime during part 2 of the study
|
CIN-107 4 mg Part 2
n=7 participants at risk
CIN-107 at 4 mg (QD) dosing anytime during part 2 of the study
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
Other adverse events
| Measure |
CIN-107 8 mg Part 2
n=7 participants at risk
CIN-107 at 8 mg (QD) dosing anytime during part 2 of the study
|
CIN-107 2 mg Part 1 - Before Titration
n=15 participants at risk
CIN-107 at 2 mg (QD) dosing before titration Visit 4 (Week 4) .
|
CIN-107 2 mg Part 1 - After Titration
n=3 participants at risk
CIN-107 at 2 mg (QD) dosing anytime after titration Week 4 until the end of Part 1.
|
CIN-107 4 mg Part 1 - After Titration
n=13 participants at risk
CIN-107 at 4 mg (QD) dosing anytime after titration Week 4 until the end of Part 1
|
CIN-107 8 mg Part 1 - After Titration
n=8 participants at risk
CIN-107 at 8 mg (QD) dosing anytime after titration Week 8 until the end of Part 1
|
CIN-107 2 mg Part 2
n=4 participants at risk
CIN-107 at 2 mg (QD) dosing anytime during part 2 of the study
|
CIN-107 4 mg Part 2
n=7 participants at risk
CIN-107 at 4 mg (QD) dosing anytime during part 2 of the study
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
General disorders
Fatigue
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
13.3%
2/15 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
General disorders
Oedema peripheral
|
28.6%
2/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
General disorders
Pain
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
General disorders
Vessel puncture site thrombosis
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
33.3%
1/3 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Covid-19
|
28.6%
2/7 • Number of events 3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Dermatophytosis of nail
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Pyuria
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
50.0%
2/4 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Injury, poisoning and procedural complications
Extraskeletal ossification
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Blood creatinine increased
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
50.0%
2/4 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Blood potassium increased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Blood pressure increased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Blood urea increased
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Blood uric acid increased
|
14.3%
1/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Glomerular filtration rate decreased
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Glycosylated haemoglobin increased
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Lipase abnormal
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Lipase increased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Red cell distribution width increased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Weight decreased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
Weight increased
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Investigations
White blood cells urine
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Metabolism and nutrition disorders
Acidosis hyperchloraemic
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
50.0%
2/4 • Number of events 3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
42.9%
3/7 • Number of events 4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Endocrine disorders
Hypogonadism
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
15.4%
2/13 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
14.3%
1/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
26.7%
4/15 • Number of events 4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
15.4%
2/13 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
28.6%
2/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Nervous system disorders
Paraesthesia
|
14.3%
1/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Nervous system disorders
Parosmia
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Renal and urinary disorders
Acute kidney injury
|
28.6%
2/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
33.3%
1/3 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Renal and urinary disorders
Renal impairment
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
33.3%
1/3 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
25.0%
1/4 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
7.7%
1/13 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
15.4%
2/13 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 2 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
12.5%
1/8 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Vascular disorders
Labile blood pressure
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Vascular disorders
Thrombophlebitis
|
14.3%
1/7 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/15 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
6.7%
1/15 • Number of events 1 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/3 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/13 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/8 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/4 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
0.00%
0/7 • From first dose of study drug to the end of the study at week 74. Note that the study was divided in 2 parts: Part 1 starting at the date of first dose and ending at Week 12 with an additional safety follow-up at Week 14 for those opting out of part 2 while Part 2 starts at Week 12 and ends at Week 72 with an additional safety follow-up at Week 74.
An AE is defined as any untoward medical occurrence in a clinical investigation that occurs to a patient administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs were collected from the beginning of the study until Week 74. Participants are reported under the dose level they were on prior to the start of the AE. Since participants dosing changed during the course of the study, a participant can be counted under multiple dose levels.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place