Trial Outcomes & Findings for A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) (NCT NCT03525444)
NCT ID: NCT03525444
Last Updated: 2020-05-19
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
405 participants
Primary outcome timeframe
From Baseline at Week 4
Results posted on
2020-05-19
Participant Flow
A total of 405 participants were enrolled in the study, of which 2 participants were enrolled but were not dosed in the triple combination (TC) treatment period. Results are presented for 403 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-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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
|
203
|
200
|
|
Overall Study
Safety Set
|
201
|
202
|
|
Overall Study
COMPLETED
|
203
|
197
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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
|
0
|
1
|
|
Overall Study
Withdrawal of consent (not due to AE)
|
0
|
1
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
A Phase 3 Study of VX-445 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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
25.6 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
26.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
175 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race
Not Collected per Local Regulations
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race
Australian Aboriginal
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race
Not Otherwise Specified
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race
Other- Unknown Mixed Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race
White
|
182 Participants
n=5 Participants
|
185 Participants
n=7 Participants
|
367 Participants
n=5 Participants
|
|
Race
White, Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race
White, Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Forced Expiratory Volume in 1 Second (ppFEV1)
|
61.3 percentage points
STANDARD_DEVIATION 15.5 • n=5 Participants
|
61.6 percentage points
STANDARD_DEVIATION 15.0 • n=7 Participants
|
61.4 percentage points
STANDARD_DEVIATION 15.2 • 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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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)
|
-0.2 percentage points
Standard Error 0.6
|
13.6 percentage points
Standard Error 0.6
|
SECONDARY outcome
Timeframe: From Baseline through Week 24Population: FAS.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Outcome measures
| Measure |
Placebo
n=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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)
|
-0.4 percentage points
Standard Error 0.5
|
13.9 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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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)
|
113 pulmonary exacerbation events
|
41 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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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)
|
-0.4 millimole per liter (mmol/L)
Standard Error 0.9
|
-42.2 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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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
|
-2.7 units on a scale
Standard Error 1.0
|
17.5 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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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)
|
0.09 kilogram per meter square (kg/m^2)
Standard Error 0.07
|
1.13 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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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
|
0.1 mmol/L
Standard Error 1.0
|
-41.2 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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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
|
-1.9 units on a scale
Standard Error 1.1
|
18.1 units on a scale
Standard Error 1.1
|
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=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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=74 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=71 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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
|
0.04 z-score
Standard Error 0.05
|
0.34 z-score
Standard Error 0.05
|
SECONDARY outcome
Timeframe: From Baseline at Week 24Population: FAS.
Outcome measures
| Measure |
Placebo
n=203 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=200 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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
|
0.5 kg
Standard Error 0.2
|
3.4 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
Outcome measures
| Measure |
Placebo
n=201 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=202 Participants
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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
|
193 Participants
|
188 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
|
42 Participants
|
28 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=200 Participants
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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-445, TEZ, M1-TEZ, and IVA
VX-445 (Week 16)
|
4.75 microgram per milliliter (mcg/mL)
Standard Deviation 2.58
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
TEZ (Week 4)
|
2.16 microgram per milliliter (mcg/mL)
Standard Deviation 1.05
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
TEZ (Week 8)
|
2.14 microgram per milliliter (mcg/mL)
Standard Deviation 1.14
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
TEZ (Week 12)
|
2.22 microgram per milliliter (mcg/mL)
Standard Deviation 1.48
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
TEZ (Week 16)
|
2.32 microgram per milliliter (mcg/mL)
Standard Deviation 1.46
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
M1-TEZ (Week 4)
|
5.18 microgram per milliliter (mcg/mL)
Standard Deviation 2.01
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
VX-445 (Week 4)
|
5.02 microgram per milliliter (mcg/mL)
Standard Deviation 2.68
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
VX-445 (Week 8)
|
4.90 microgram per milliliter (mcg/mL)
Standard Deviation 2.75
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
VX-445 (Week 12)
|
4.99 microgram per milliliter (mcg/mL)
Standard Deviation 3.11
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
M1-TEZ (Week 8)
|
5.09 microgram per milliliter (mcg/mL)
Standard Deviation 1.95
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
M1-TEZ (Week 12)
|
5.06 microgram per milliliter (mcg/mL)
Standard Deviation 1.92
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
M1-TEZ (Week 16)
|
5.29 microgram per milliliter (mcg/mL)
Standard Deviation 1.95
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
IVA (Week 4)
|
0.748 microgram per milliliter (mcg/mL)
Standard Deviation 0.471
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
IVA (Week 8)
|
0.738 microgram per milliliter (mcg/mL)
Standard Deviation 0.484
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
IVA (Week 12)
|
0.758 microgram per milliliter (mcg/mL)
Standard Deviation 0.572
|
—
|
|
Observed Pre-dose Concentration (Ctrough) of VX-445, TEZ, M1-TEZ, and IVA
IVA (Week 16)
|
0.778 microgram per milliliter (mcg/mL)
Standard Deviation 0.516
|
—
|
Adverse Events
Placebo
Serious events: 42 serious events
Other events: 180 other events
Deaths: 0 deaths
VX-445/TEZ/IVA TC
Serious events: 28 serious events
Other events: 168 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=201 participants at risk
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=202 participants at risk
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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.
|
|---|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
16.4%
33/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
5.4%
11/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
1.5%
3/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Atypical mycobacterial lower respiratory tract infection
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Coccidioidomycosis
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Genital herpes simplex
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Lung infection
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Viral sinusitis
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.5%
3/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.99%
2/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.99%
2/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Nervous system disorders
Axonal neuropathy
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Nervous system disorders
Neuroglycopenia
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
General disorders
Medical device site inflammation
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Psychiatric disorders
Depression
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Psychiatric disorders
Suicidal ideation
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Renal and urinary disorders
Renal colic
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
1/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.00%
0/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
0.50%
1/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
Other adverse events
| Measure |
Placebo
n=201 participants at risk
Participants who received placebo matched to VX-445/TEZ/IVA in the morning and placebo matched to IVA in the evening for 24 weeks in the TC treatment period.
|
VX-445/TEZ/IVA TC
n=202 participants at risk
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
38.3%
77/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
16.8%
34/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
19.4%
39/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
19.8%
40/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.4%
25/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
9.9%
20/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
13.4%
27/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
4.5%
9/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.5%
15/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
9.4%
19/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.0%
16/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
5.9%
12/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.0%
6/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
8.4%
17/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.5%
13/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
2.5%
5/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
41.3%
83/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
20.3%
41/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
12.9%
26/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
10.9%
22/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.9%
22/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
11.9%
24/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Rhinitis
|
5.5%
11/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
7.4%
15/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Sinusitis
|
4.0%
8/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
5.4%
11/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Infections and infestations
Influenza
|
1.5%
3/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
5.9%
12/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
14/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
12.9%
26/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
12/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
9.9%
20/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
14/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
7.9%
16/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
10/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
5.9%
12/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
12/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
3.0%
6/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Alanine aminotransferase increased
|
3.5%
7/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
9.9%
20/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.5%
9/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
9.4%
19/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
4/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
9.4%
19/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Bacterial test positive
|
5.0%
10/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
2.5%
5/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Investigations
Blood bilirubin increased
|
1.00%
2/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
5.0%
10/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Nervous system disorders
Headache
|
14.9%
30/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
17.3%
35/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
General disorders
Pyrexia
|
9.5%
19/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
8.4%
17/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
General disorders
Fatigue
|
10.0%
20/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
4.5%
9/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
9/201 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/TEZ/IVA TC group for the purpose of safety analysis.
|
8.4%
17/202 • 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 2 participants assigned to Placebo group who inadvertently received one or more doses of VX-445/TEZ/IVA TC regimen were included in VX-445/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