Trial Outcomes & Findings for A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) (NCT NCT03447249)
NCT ID: NCT03447249
Last Updated: 2020-03-13
Results Overview
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
385 participants
Primary outcome timeframe
From Baseline at Week 4
Results posted on
2020-03-13
Participant Flow
A total of 385 participants were enrolled in the study, of which 3 participants were enrolled but were not dosed in the TC treatment period. Results are presented for 382 participants dosed in the TC treatment period.
This study was conducted in participants with cystic fibrosis (CF) aged 12 years or older.
Participant milestones
| Measure |
Placebo
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Overall Study
STARTED
|
190
|
192
|
|
Overall Study
Safety Set
|
189
|
193
|
|
Overall Study
COMPLETED
|
185
|
192
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal of consent (not due to AE)
|
1
|
0
|
|
Overall Study
Other
|
3
|
0
|
Baseline Characteristics
A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Baseline characteristics by cohort
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
Total
n=382 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
26.7 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
26.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
214 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
181 Participants
n=5 Participants
|
184 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race
White
|
187 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
375 Participants
n=5 Participants
|
|
Race
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race
Both White and Black/African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Forced Expiratory Volume in 1 Second (ppFEV1)
|
60.4 percentage points
STANDARD_DEVIATION 14.5 • n=5 Participants
|
60.7 percentage points
STANDARD_DEVIATION 15.4 • n=7 Participants
|
60.6 percentage points
STANDARD_DEVIATION 14.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline at Week 4Population: Analysis population included all participants in the Full Analysis Set (all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug) who completed the Week 4 Visit or were randomized at least 28 days before the data cutoff date.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
-1.0 percentage points
Standard Error 0.6
|
13.0 percentage points
Standard Error 0.6
|
SECONDARY outcome
Timeframe: From Baseline through Week 24Population: Full analysis set (FAS) included all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug in the TC Treatment Period.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
|
-0.8 percentage points
Standard Error 0.6
|
13.4 percentage points
Standard Error 0.6
|
SECONDARY outcome
Timeframe: From Baseline through Week 24Population: FAS.
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 |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Number of Pulmonary Exacerbations (PEx)
|
116 pulmonary exacerbation events
|
17 pulmonary exacerbation events
|
SECONDARY outcome
Timeframe: From Baseline through Week 24Population: FAS.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in Sweat Chloride (SwCl)
|
-0.1 millimole per liter (mmol/L)
Standard Error 1.0
|
-44.6 millimole per liter (mmol/L)
Standard Error 0.9
|
SECONDARY outcome
Timeframe: From Baseline through Week 24Population: FAS.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score
|
-1.5 units on a scale
Standard Error 1.1
|
18.6 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: From Baseline at Week 24Population: FAS.
BMI was defined as weight in kilogram (kg) divided by height in square meter (m\^2).
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in Body Mass Index (BMI)
|
-0.05 kilogram per meter square (kg/m^2)
Standard Error 0.07
|
1.06 kilogram per meter square (kg/m^2)
Standard Error 0.07
|
SECONDARY outcome
Timeframe: From Baseline at Week 4Population: FAS.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in Sweat Chloride
|
0.0 mmol/L
Standard Error 1.0
|
-43.3 mmol/L
Standard Error 1.0
|
SECONDARY outcome
Timeframe: From Baseline at Week 4Population: FAS.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score
|
0.1 units on a scale
Standard Error 1.2
|
18.0 units on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: From Baseline through Week 24Population: FAS.
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 |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Time-to-first Pulmonary Exacerbation (PEx)
|
NA days
Median and 95% confidence interval could not be estimated because less than 50% of participants had events.
|
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 24Population: FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were \<=20 years of age at 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.
Outcome measures
| Measure |
Placebo
n=59 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=58 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in BMI Z-score for Participants <=20 Years of Age at Baseline
|
-0.08 kg/m^2
Standard Error 0.05
|
0.31 kg/m^2
Standard Error 0.05
|
SECONDARY outcome
Timeframe: From Baseline at Week 24Population: FAS.
Outcome measures
| Measure |
Placebo
n=190 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=192 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Absolute Change in Body Weight
|
0.1 kg
Standard Error 0.2
|
3.3 kg
Standard Error 0.2
|
SECONDARY outcome
Timeframe: From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)Population: Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
Outcome measures
| Measure |
Placebo
n=189 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=193 Participants
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
175 participants
|
173 participants
|
|
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with Serious TEAEs
|
58 participants
|
11 participants
|
SECONDARY outcome
Timeframe: Pre-dose on Week 4, 8, 12, and 16Population: Pharmacokinetic (PK) set included all randomized participants who carried the intended CFTR allele mutation and received at least 1 dose of study drug in the TC Treatment Period. Here "Number Analyzed" signifies those participants who were evaluable for this outcome measure at specified time points.
Outcome measures
| Measure |
Placebo
n=192 Participants
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
VX-659 (Week 4)
|
662 nanogram per milliliter (ng/mL)
Standard Deviation 528
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
VX-659 (Week 8)
|
764 nanogram per milliliter (ng/mL)
Standard Deviation 1520
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
VX-659 (Week 12)
|
614 nanogram per milliliter (ng/mL)
Standard Deviation 519
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
VX-659 (Week 16)
|
638 nanogram per milliliter (ng/mL)
Standard Deviation 521
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
TEZ (Week 4)
|
1220 nanogram per milliliter (ng/mL)
Standard Deviation 645
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
TEZ (Week 8)
|
1390 nanogram per milliliter (ng/mL)
Standard Deviation 1250
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
TEZ (Week 12)
|
1290 nanogram per milliliter (ng/mL)
Standard Deviation 766
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
TEZ (Week 16)
|
1220 nanogram per milliliter (ng/mL)
Standard Deviation 654
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
M1-TEZ (Week 4)
|
4380 nanogram per milliliter (ng/mL)
Standard Deviation 1560
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
M1-TEZ (Week 8)
|
4580 nanogram per milliliter (ng/mL)
Standard Deviation 1480
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
M1-TEZ (Week 12)
|
4580 nanogram per milliliter (ng/mL)
Standard Deviation 1530
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
M1-TEZ (Week 16)
|
4420 nanogram per milliliter (ng/mL)
Standard Deviation 1520
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
IVA (Week 4)
|
442 nanogram per milliliter (ng/mL)
Standard Deviation 277
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
IVA (Week 8)
|
548 nanogram per milliliter (ng/mL)
Standard Deviation 1100
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
IVA (Week 12)
|
429 nanogram per milliliter (ng/mL)
Standard Deviation 327
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
IVA (Week 16)
|
416 nanogram per milliliter (ng/mL)
Standard Deviation 303
|
—
|
Adverse Events
Placebo
Serious events: 58 serious events
Other events: 166 other events
Deaths: 0 deaths
VX-659/TEZ/IVA TC
Serious events: 11 serious events
Other events: 141 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=189 participants at risk
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=193 participants at risk
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Psychiatric disorders
Intentional self-injury
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Forced expiratory volume decreased
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Weight decreased
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Cardiac disorders
Pericardial effusion
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Congenital, familial and genetic disorders
Right-to-left cardiac shunt
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
3/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
1.1%
2/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Product Issues
Device damage
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Axillary mass
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
23.8%
45/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
1.6%
3/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
1.1%
2/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Bronchitis
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Dysentery
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.52%
1/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Vascular device infection
|
0.53%
1/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
Other adverse events
| Measure |
Placebo
n=189 participants at risk
Participants who received placebo matched to VX-659/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-659/TEZ/IVA TC
n=193 participants at risk
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as FDC tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
|
|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
1.1%
2/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
8.8%
17/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.7%
7/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
6.7%
13/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
2.1%
4/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
8.3%
16/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.0%
68/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
17.6%
34/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.9%
13/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
10.4%
20/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
20.1%
38/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
14.5%
28/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.1%
19/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
3.1%
6/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
7.4%
14/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
3.6%
7/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.4%
14/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
1.6%
3/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Nervous system disorders
Headache
|
16.4%
31/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
13.5%
26/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
General disorders
Pyrexia
|
7.9%
15/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
6.7%
13/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
General disorders
Fatigue
|
10.1%
19/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
4.7%
9/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
16/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
8.8%
17/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
12.7%
24/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
4.1%
8/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.3%
10/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
1.6%
3/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
11/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
3.6%
7/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
2.6%
5/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
5.7%
11/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
10/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
5.2%
10/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
41.8%
79/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
10.9%
21/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
7/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
18.1%
35/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
16/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
13.5%
26/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.8%
11/189 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
5.7%
11/193 • From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Adverse events are presented as per Safety Set. Group assignments for participants in the Safety Set were based on actual treatment received, such that 1 participant assigned to Placebo group who inadvertently received one or more doses of VX-659/TEZ/IVA TC regimen was included in VX-659/TEZ/IVA TC group for the purpose of safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place