Trial Outcomes & Findings for Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy (NCT NCT04058366)
NCT ID: NCT04058366
Last Updated: 2024-01-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
251 participants
Primary outcome timeframe
From Baseline up to Week 100
Results posted on
2024-01-16
Participant Flow
The study was conducted as a single part study (Part A) in countries including United States (US), and the protocol for other countries was amended as a regional protocol so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B.
Participants from parent study VX18-445-104 (NCT04058353) were enrolled in this study. A total of 251 participants were enrolled in this study.
Participant milestones
| Measure |
ELX/TEZ/IVA
Part A: Participants received ELX (elexacaftor) 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.
Part B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|
|
Overall Study
STARTED
|
251
|
|
Overall Study
COMPLETED
|
215
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
ELX/TEZ/IVA
Part A: Participants received ELX (elexacaftor) 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.
Part B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Withdrawal of Consent (not due to AE)
|
7
|
|
Overall Study
Commercial drug is available for participants
|
6
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other non-compliance
|
2
|
|
Overall Study
Other
|
6
|
Baseline Characteristics
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
Baseline characteristics by cohort
| Measure |
ELX/TEZ/IVA
n=251 Participants
Part A: Participants received ELX 200mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
Part B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 14.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
224 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not collected per local regulations
|
18 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
225 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to Week 100Population: The open label (OL) Safety Set for Part A was defined as all participants who received at least 1 dose of study drug in the OLS Part A (participants were assigned based on parent study actual treatment).
Outcome measures
| Measure |
Part A: ELX/TEZ/IVA
n=251 Participants
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
|---|---|
|
Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
241 Participants
|
|
Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
38 Participants
|
SECONDARY outcome
Timeframe: From Baseline at Week 96Population: The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here "Number Analyzed" signifies participants who were evaluable for the specified category.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Part A: ELX/TEZ/IVA
n=176 Participants
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
|---|---|
|
Part A: Absolute Change From Parent Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Control-IVA or TEZ/IVA: Change at Week 96
|
4.1 percentage points
Interval 2.5 to 5.7
|
|
Part A: Absolute Change From Parent Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
ELX/TEZ/IVA: Change at Week 96
|
3.7 percentage points
Interval 2.2 to 5.2
|
SECONDARY outcome
Timeframe: From Baseline at Week 96Population: The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Part A: ELX/TEZ/IVA
n=186 Participants
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
|---|---|
|
Part A: Absolute Change From Parent Study Baseline in Sweat Chloride (SwCl)
Control-IVA or TEZ/IVA: Change at Week 96
|
-23.0 millimole per liter (mmol/L)
Interval -25.8 to -20.1
|
|
Part A: Absolute Change From Parent Study Baseline in Sweat Chloride (SwCl)
ELX/TEZ/IVA: Change at Week 96
|
-22.6 millimole per liter (mmol/L)
Interval -25.4 to -19.9
|
SECONDARY outcome
Timeframe: From Baseline at Week 96Population: The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.
BMI was defined as weight in kilogram (kg) divided by height in square meter (m\^2).
Outcome measures
| Measure |
Part A: ELX/TEZ/IVA
n=207 Participants
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
|---|---|
|
Part A: Absolute Change From Parent Study Baseline in Body Mass Index (BMI)
Control-IVA or TEZ/IVA: Change at Week 96
|
1.15 kg/m^2
Interval 0.84 to 1.45
|
|
Part A: Absolute Change From Parent Study Baseline in Body Mass Index (BMI)
ELX/TEZ/IVA: Change at Week 96
|
0.83 kg/m^2
Interval 0.54 to 1.11
|
SECONDARY outcome
Timeframe: From Baseline at Week 96Population: The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.
BMI was defined as weight in kilogram (kg) divided by squared height in meters (m\^2). The z-score is a statistical measure to describe whether a value was above or below the standard. A z-score of 0 is equal to the standard. Lower numbers indicate values lower than the standard and higher numbers indicate values higher than the standard.
Outcome measures
| Measure |
Part A: ELX/TEZ/IVA
n=18 Participants
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
|---|---|
|
Part A: Absolute Change From Parent Study Baseline in BMI Z-score
Control-IVA or TEZ/IVA: Change at Week 96
|
0.11 z-score
Interval -0.17 to 0.4
|
|
Part A: Absolute Change From Parent Study Baseline in BMI Z-score
ELX/TEZ/IVA: Change at Week 96
|
0.40 z-score
Interval 0.17 to 0.62
|
SECONDARY outcome
Timeframe: From Baseline at Week 96Population: The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled subjects who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.
Outcome measures
| Measure |
Part A: ELX/TEZ/IVA
n=207 Participants
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
|---|---|
|
Part A: Absolute Change From Parent Study Baseline in Body Weight
Control-IVA or TEZ/IVA: Change at Week 96
|
3.6 Kilogram (Kg)
Interval 2.7 to 4.6
|
|
Part A: Absolute Change From Parent Study Baseline in Body Weight
ELX/TEZ/IVA: Change at Week 96
|
2.9 Kilogram (Kg)
Interval 2.0 to 3.8
|
SECONDARY outcome
Timeframe: From Baseline at Week 96Population: The OL Full Analysis Set (OL-FAS) for Part A is defined as all enrolled participants who have received at least 1 dose of study drug in the open-label study. This analysis set included study 104 parent study participants who received Control IVA or TEZ/IVA and ELX/TEZ/IVA. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome. Here, "Number Analyzed" signifies participants who were evaluable for the specified category.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Part A: ELX/TEZ/IVA
n=208 Participants
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
|---|---|
|
Part A: Absolute Change From Parent Study Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
Control-IVA or TEZ/IVA: Change at Week 96
|
7.2 units on a scale
Interval 4.1 to 10.4
|
|
Part A: Absolute Change From Parent Study Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
ELX/TEZ/IVA: Change at Week 96
|
8.1 units on a scale
Interval 5.1 to 11.1
|
Adverse Events
Part A: ELX/TEZ/IVA
Serious events: 38 serious events
Other events: 223 other events
Deaths: 1 deaths
Part B: ELX/TEZ/IVA
Serious events: 3 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: ELX/TEZ/IVA
n=251 participants at risk
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
Part B: ELX/TEZ/IVA
n=84 participants at risk
Part B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Cardiac disorders
Palpitations
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Eye disorders
Vision blurred
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Gastritis
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Haematochezia
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Chest pain
|
0.00%
0/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Aspergilloma
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
COVID-19
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.80%
2/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
6.4%
16/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Alanine aminotransferase increased
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
C-reactive protein increased
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Nervous system disorders
Hypoaesthesia
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Nervous system disorders
Paraesthesia
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Anxiety
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Depression
|
0.00%
0/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Suicidal ideation
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.80%
2/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Reproductive system and breast disorders
Epididymal cyst
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.2%
3/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.80%
2/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Vascular disorders
Hypertension
|
0.40%
1/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
Other adverse events
| Measure |
Part A: ELX/TEZ/IVA
n=251 participants at risk
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks.
|
Part B: ELX/TEZ/IVA
n=84 participants at risk
Part B: Participants from certain countries participated in Part B and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.2%
13/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
2.4%
2/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Constipation
|
6.8%
17/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.1%
48/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
4.8%
4/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.2%
13/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Nausea
|
11.2%
28/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
2.4%
2/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Fatigue
|
15.9%
40/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Pyrexia
|
14.3%
36/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
2.4%
2/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
COVID-19
|
20.7%
52/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
20.2%
17/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
24.3%
61/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
20.2%
17/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Nasopharyngitis
|
15.9%
40/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
8.3%
7/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
15/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
7.1%
6/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
11.2%
28/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Alanine aminotransferase increased
|
6.4%
16/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
6.4%
16/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Blood creatine phosphokinase increased
|
10.4%
26/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
27/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
2.4%
2/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
20/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
2.4%
2/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
16/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
13/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Nervous system disorders
Headache
|
28.3%
71/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
4.8%
4/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Anxiety
|
11.2%
28/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Depression
|
6.4%
16/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Insomnia
|
6.0%
15/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
2.4%
2/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.9%
65/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
6.0%
5/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.6%
29/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
2.4%
2/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.0%
20/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
6.0%
5/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.2%
18/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
42/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
6.0%
5/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.8%
17/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.2%
1/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.6%
19/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
6.0%
15/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
13.5%
34/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
3.6%
3/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.6%
19/251 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/84 • Day 1 through Safety follow-up (up to Week 100 for Part A and up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) and the protocol for other countries was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 24.1 applied for Part A and MedDRA 25.1 applied for Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place