Trial Outcomes & Findings for A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy (NCT NCT03525574)
NCT ID: NCT03525574
Last Updated: 2025-09-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
507 participants
Primary outcome timeframe
From Day 1 up to Week 196
Results posted on
2025-09-24
Participant Flow
The study was conducted as a single period i.e. treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period.
A total 507 participants were enrolled in this study from the parent studies VX17-445-102 (NCT03525444) and VX17-445-103 (NCT03525548). One participant was enrolled but did not receive any dose in this study.
Participant milestones
| Measure |
ELX/TEZ/IVA
Treatment Period: Participants received ELX 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hrs (q12h) in the treatment period for 192 weeks.
Extension Period: Participants from certain countries participated in extension period and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the extension period for 48 weeks.
|
Additional Participants for Cumulative TC Efficacy Set
This reporting arm represents the three additional participants in Cumulative TC Efficacy Set 102/105 from parent study 102 which were not not enrolled in this study, but were included in the Cumulative TC efficacy 102/105 analysis set.
|
|---|---|---|
|
Overall Study
STARTED
|
507
|
3
|
|
Overall Study
Open-Label Safety Set (OL-SS)
|
506
|
0
|
|
Overall Study
OL-FAS 102/105
|
399
|
0
|
|
Overall Study
OL-FAS 103/105
|
107
|
0
|
|
Overall Study
Cumulative Triple Combination (TC) Efficacy Set 102/105
|
400
|
3
|
|
Overall Study
Cumulative TC Efficacy Set 103/105
|
107
|
0
|
|
Overall Study
COMPLETED
|
354
|
0
|
|
Overall Study
NOT COMPLETED
|
153
|
3
|
Reasons for withdrawal
| Measure |
ELX/TEZ/IVA
Treatment Period: Participants received ELX 200 milligram (mg) once daily (qd)/TEZ 100 mg qd/IVA 150 mg every 12 hrs (q12h) in the treatment period for 192 weeks.
Extension Period: Participants from certain countries participated in extension period and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the extension period for 48 weeks.
|
Additional Participants for Cumulative TC Efficacy Set
This reporting arm represents the three additional participants in Cumulative TC Efficacy Set 102/105 from parent study 102 which were not not enrolled in this study, but were included in the Cumulative TC efficacy 102/105 analysis set.
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
0
|
|
Overall Study
Withdrawal of consent (not due to AE)
|
18
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Commercial drug is Available for participant
|
48
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Other non-compliance
|
2
|
0
|
|
Overall Study
Physician Decision
|
6
|
0
|
|
Overall Study
Other
|
58
|
0
|
|
Overall Study
Enrolled but never dosed
|
1
|
0
|
|
Overall Study
Not enrolled in 105 study
|
0
|
3
|
Baseline Characteristics
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
Baseline characteristics by cohort
| Measure |
ELX/TEZ/IVA
n=506 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
Extension Period: Participants from certain countries participated in extension period and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the extension period for 48 weeks.
|
|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
251 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
255 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
460 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not collected per local regulations
|
25 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
470 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
3 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Week 196Population: The Open-Label Safety Set (OL-SS) included all participants who had received at least 1 dose of study drug in this open label study.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=506 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Treatment Period: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants With TEAEs
|
504 Participants
|
|
Treatment Period: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants With SAEs
|
175 Participants
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS is defined as all enrolled participants who received at least 1 dose of study drug in this open label study. 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. Baseline was defined as the parent study baseline.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. This analysis set included study 102 parent study participants who received Placebo-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=269 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 102/105 Efficacy Set
Placebo-ELX/TEZ/IVA
|
15.3 percentage points
Standard Error 0.8
|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 102/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
13.8 percentage points
Standard Error 0.8
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. This analysis set included study 103 parent study participants who received TEZ/IVA-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=68 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 103/105 Efficacy Set
TEZ/IVA-ELX/TEZ/IVA
|
10.9 percentage points
Standard Error 1.3
|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) for 103/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
10.7 percentage points
Standard Error 1.3
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
Sweat samples were collected using an approved collection device. This analysis set included study 102 parent study participants who received Placebo-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=261 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in Sweat Chloride (SwCl) for 102/105 Efficacy Set
Placebo-ELX/TEZ/IVA
|
-47.0 millimole per liter (mmol/L)
Standard Error 1.6
|
|
Absolute Change in Sweat Chloride (SwCl) for 102/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
-45.3 millimole per liter (mmol/L)
Standard Error 1.6
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
Sweat samples were collected using an approved collection device. This analysis set included study 103 parent study participants who received TEZ/IVA-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=69 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in Sweat Chloride (SwCl) for 103/105 Efficacy Set
TEZ/IVA-ELX/TEZ/IVA
|
-48.2 mmol/L
Standard Error 3.8
|
|
Absolute Change in Sweat Chloride (SwCl) for 103/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
-48.2 mmol/L
Standard Error 3.5
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: Cumulative TC Efficacy Set 102/105 included all participants who were randomized to TC ELX/TEZ/IVA and received at least 1 dose of study drug during the parent study 102 and/or received at least 1 dose of study drug during this open label study. Baseline was defined as the parent study baseline.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=403 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Number of Pulmonary Exacerbations (PEx) for 102/105 Efficacy Set
|
174 PEx events
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: Cumulative TC Efficacy Set 103/105 included all participants who were randomized to TC ELX/TEZ/IVA and received at least 1 dose of study drug during the parent study 103 and/or received at least 1 dose of study drug during this open label study. Baseline was defined as the parent study baseline.
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=107 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Number of Pulmonary Exacerbations (PEx) for 103/105 Efficacy Set
|
43 PEx events
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: Cumulative TC Efficacy Set 102/105 included all participants who were randomized to TC ELX/TEZ/IVA and received at least 1 dose of study drug during the parent study 102 and/or received at least 1 dose of study drug during this open label study. Baseline was defined as the parent study baseline.
Time-to-first pulmonary exacerbation was analyzed using Kaplan-Meier estimates and expressed in terms of event-free probability. PEx was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=403 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Time to First PEx for 102/105 Efficacy Set
|
NA days
Median and 95% confidence interval could not be estimated because less than 50% of participants had events.
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: Cumulative TC Efficacy Set 103/105 included all participants who were randomized to TC ELX/TEZ/IVA and received at least 1 dose of study drug during the parent study 103 and/or received at least 1 dose of study drug during this open label study. Baseline was defined as the parent study baseline.
Time-to-first pulmonary exacerbation was analyzed using Kaplan-Meier estimates and expressed in terms of event-free probability. PEx was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=107 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Time to First PEx for 103/105 Efficacy Set
|
NA days
Median and 95% confidence interval could not be estimated because less than 50% of participants had events.
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
BMI was defined as weight in kilogram (kg) divided by height in square meter (m\^2).This analysis set included study 102 parent study participants who received Placebo-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=283 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in Body Mass Index (BMI) for 102/105 Efficacy Set
Placebo-ELX/TEZ/IVA
|
1.81 kilogram per meter square (kg/m^2)
Standard Error 0.16
|
|
Absolute Change in Body Mass Index (BMI) for 102/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
1.74 kilogram per meter square (kg/m^2)
Standard Error 0.16
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
BMI was defined as weight in kilogram (kg) divided by height in square meter (m\^2).This analysis set included study 103 parent study participants who received TEZ/IVA-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=74 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in Body Mass Index (BMI) for 103/105 Efficacy Set
TEZ/IVA-ELX/TEZ/IVA
|
1.72 kg/m^2
Standard Error 0.24
|
|
Absolute Change in Body Mass Index (BMI) for 103/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
1.85 kg/m^2
Standard Error 0.22
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were \<=20 years of age at Baseline. Here "Number Analyzed" signifies participants who were evaluable for the specified category. Baseline was defined as the parent study baseline.
BMI was defined as weight in kg divided by height in m\^2. Z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI. This analysis set included study 102 parent study participants who received Placebo-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=57 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in BMI Z-score for 102/105 Efficacy Set
Placebo-ELX/TEZ/IVA
|
0.24 z-score
Standard Error 0.09
|
|
Absolute Change in BMI Z-score for 102/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
0.18 z-score
Standard Error 0.09
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were \<=20 years of age at Baseline. Here "Number Analyzed" signifies participants who were evaluable for the specified category. Baseline was defined as the parent study baseline.
BMI was defined as weight in kg divided by height in m\^2. Z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI. This analysis set included study 103 parent study participants who received TEZ/IVA-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=15 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in BMI Z-score for 103/105 Efficacy Set
TEZ/IVA-ELX/TEZ/IVA
|
0.36 z-score
Standard Error 0.14
|
|
Absolute Change in BMI Z-score for 103/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
0.24 z-score
Standard Error 0.15
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
This analysis set included study 102 parent study participants who received Placebo-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=283 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in Body Weight for 102/105 Efficacy Set
Placebo-ELX/TEZ/IVA
|
6.6 kg
Standard Error 0.5
|
|
Absolute Change in Body Weight for 102/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
6.0 kg
Standard Error 0.5
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
This analysis set included study 103 parent study participants who received TEZ/IVA and ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=74 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change in Body Weight for 103/105 Efficacy Set
TEZ/IVA-ELX/TEZ/IVA
|
6.1 kg
Standard Error 0.8
|
|
Absolute Change in Body Weight for 103/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
6.3 kg
Standard Error 0.7
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
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. This analysis set included study 102 parent study participants who received Placebo-ELX/TEZ/IVA and ELX/TEZ/IVA-ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=295 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for 102/105 Efficacy Set
Placebo-ELX/TEZ/IVA
|
15.3 units on a scale
Standard Error 1.5
|
|
Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for 102/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
18.3 units on a scale
Standard Error 1.5
|
SECONDARY outcome
Timeframe: From Baseline at Week 192Population: OL-FAS. 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. Baseline was defined as the parent study baseline.
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. This analysis set included study 103 parent study participants who received TEZ/IVA and ELX/TEZ/IVA.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=75 Participants
Treatment Period: Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
|---|---|
|
Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for 103/105 Efficacy Set
TEZ/IVA-ELX/TEZ/IVA
|
14.8 units on a scale
Standard Error 2.6
|
|
Absolute Change From Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for 103/105 Efficacy Set
ELX/TEZ/IVA-ELX/TEZ/IVA
|
17.6 units on a scale
Standard Error 2.4
|
Adverse Events
Treatment Period: ELX/TEZ/IVA
Serious events: 175 serious events
Other events: 501 other events
Deaths: 1 deaths
Extension Period: ELX/TEZ/IVA
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Period: ELX/TEZ/IVA
n=506 participants at risk
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
Extension Period: ELX/TEZ/IVA
n=11 participants at risk
Participants from certain countries participated in extension period and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the extension period for 48 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Cardiac disorders
Arrhythmia
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis lung
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Endocrine disorders
Thyroid mass
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Eye disorders
Visual impairment
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.79%
4/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Constipation
|
1.2%
6/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
1.8%
9/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Duodenitis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Gastric fistula
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Gastritis
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Ileus
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.99%
5/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.59%
3/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Vomiting
|
0.59%
3/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Drug withdrawal syndrome
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Fatigue
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Physical deconditioning
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Pyrexia
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Immune system disorders
Drug hypersensitivity
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Bacteraemia
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Bacterial disease carrier
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
COVID-19
|
0.79%
4/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Chest wall abscess
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Chronic sinusitis
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Gastroenteritis
|
0.59%
3/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
16.4%
83/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Influenza
|
1.4%
7/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Parotitis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Pneumonia
|
1.2%
6/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Pneumonia viral
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Post procedural infection
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Postoperative wound infection
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Pyelonephritis
|
0.79%
4/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Sepsis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Sinusitis
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Urinary tract infection
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Vascular device infection
|
0.59%
3/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Fracture of penis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Alanine aminotransferase increased
|
0.99%
5/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Aspartate aminotransferase increased
|
0.99%
5/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Bacterial test positive
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Blood bilirubin increased
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Enterovirus test positive
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Human rhinovirus test positive
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Influenza A virus test positive
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Pulmonary function test decreased
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
SARS-CoV-2 test positive
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Philadelphia positive acute lymphocytic leukaemia
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Cerebellar infarction
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Miller Fisher syndrome
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Optic neuritis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Seizure
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Syncope
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Anger
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Anorexia nervosa
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Anxiety
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Bipolar disorder
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Depression
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Major depression
|
0.59%
3/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Mental disorder
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Psychotic disorder
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Suicide attempt
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Renal and urinary disorders
Calculus urinary
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.99%
5/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Renal and urinary disorders
Renal colic
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Reproductive system and breast disorders
Breast mass
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Reproductive system and breast disorders
Testicular torsion
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.2%
11/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.40%
2/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Vascular disorders
Haematoma
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Vascular disorders
Hypertensive urgency
|
0.20%
1/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
Other adverse events
| Measure |
Treatment Period: ELX/TEZ/IVA
n=506 participants at risk
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 192 weeks.
|
Extension Period: ELX/TEZ/IVA
n=11 participants at risk
Participants from certain countries participated in extension period and continued to receive ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the extension period for 48 weeks.
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
2.2%
11/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
31/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.0%
76/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.7%
49/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Constipation
|
14.2%
72/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
89/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Nausea
|
18.0%
91/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
67/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Fatigue
|
23.3%
118/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Influenza like illness
|
6.5%
33/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Malaise
|
5.1%
26/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Pain
|
7.3%
37/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
General disorders
Pyrexia
|
29.1%
147/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Immune system disorders
Immunisation reaction
|
16.4%
83/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Immune system disorders
Seasonal allergy
|
8.9%
45/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
COVID-19
|
33.2%
168/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Cystitis
|
1.6%
8/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Gastroenteritis
|
6.1%
31/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Hordeolum
|
3.6%
18/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
44.3%
224/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
27.3%
3/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Influenza
|
12.5%
63/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.4%
7/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Nasopharyngitis
|
30.4%
154/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Pharyngitis
|
7.3%
37/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Rhinitis
|
9.9%
50/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Sinusitis
|
15.0%
76/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.7%
120/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Urinary tract infection
|
8.5%
43/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.1%
36/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.3%
27/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.2%
21/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Alanine aminotransferase increased
|
14.2%
72/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Aspartate aminotransferase increased
|
13.4%
68/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Bacterial test positive
|
9.9%
50/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Blood bilirubin increased
|
6.1%
31/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Blood creatine phosphokinase increased
|
14.2%
72/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.1%
26/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Pulmonary function test decreased
|
5.9%
30/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
SARS-CoV-2 test positive
|
8.9%
45/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Investigations
Weight decreased
|
6.3%
32/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
26/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.5%
33/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.0%
71/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.1%
51/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
33/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
9/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
34/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Dizziness
|
7.5%
38/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Nervous system disorders
Headache
|
35.2%
178/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Anxiety
|
7.5%
38/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Depression
|
7.9%
40/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Psychiatric disorders
Insomnia
|
6.7%
34/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.7%
231/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.3%
62/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
16.2%
82/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
7.3%
37/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
22.3%
113/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
32.8%
166/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
9.1%
1/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.1%
61/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
6.5%
33/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
15.0%
76/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
12.3%
62/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
25.1%
127/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.5%
33/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Skin and subcutaneous tissue disorders
Acne
|
9.7%
49/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.3%
57/506 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
0.00%
0/11 • Adverse events (AE) are reported separately for both Periods. Treatment period covers 1st dose till 196 weeks in treatment period; extension period covers 1st dose in extension period till safety follow-up or end of study, whichever occurs first. The actual total duration for AE collection is up to 222 weeks.
The study was conducted as a treatment period in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for other countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in extension period. The adverse events data has been reported for both the parts separately.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place