Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation (NCT NCT03537651)
NCT ID: NCT03537651
Last Updated: 2024-04-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
Day 1 up to Week 100
Results posted on
2024-04-19
Participant Flow
The study was conducted in 2 parts, Part A and Part B. Participants from Part A also participated in Part B. The Participant flow was planned to be presented for the overall treatment arm.
This study was conducted in cystic fibrosis (CF) participants aged 6 years or older who participated in parent studies VX15-661-113 Part B (Study 113B; NCT02953314) or VX16-661-115 (Study 115; NCT03559062). Eligible participants from parent studies were enrolled in Study 116.
Participant milestones
| Measure |
TEZ/IVA
Part A: Participants weighing less than (\<)40 kilograms (kg) at Day 1 received tezacaftor (TEZ) 50 milligrams (mg) once daily (qd)/ivacaftor (IVA) 75 mg every 12 hours (q12h) and the participants weighing greater than or equals to (\>=) 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
Part B: Participants weighing \<30 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>=30 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period upto192 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A (Up to 96 Weeks)
STARTED
|
130
|
|
Part A (Up to 96 Weeks)
113B/116 FAS
|
64
|
|
Part A (Up to 96 Weeks)
113B/116 LCI FAS
|
30
|
|
Part A (Up to 96 Weeks)
115/116 FAS
|
66
|
|
Part A (Up to 96 Weeks)
115/116 FAS (TEZ/IVA Group)
|
53
|
|
Part A (Up to 96 Weeks)
COMPLETED
|
69
|
|
Part A (Up to 96 Weeks)
NOT COMPLETED
|
61
|
|
Part B (Up to 192 Weeks)
STARTED
|
62
|
|
Part B (Up to 192 Weeks)
113B/116 FAS
|
9
|
|
Part B (Up to 192 Weeks)
115/116 FAS
|
53
|
|
Part B (Up to 192 Weeks)
COMPLETED
|
3
|
|
Part B (Up to 192 Weeks)
NOT COMPLETED
|
59
|
Reasons for withdrawal
| Measure |
TEZ/IVA
Part A: Participants weighing less than (\<)40 kilograms (kg) at Day 1 received tezacaftor (TEZ) 50 milligrams (mg) once daily (qd)/ivacaftor (IVA) 75 mg every 12 hours (q12h) and the participants weighing greater than or equals to (\>=) 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
Part B: Participants weighing \<30 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>=30 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period upto192 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A (Up to 96 Weeks)
Adverse Event
|
2
|
|
Part A (Up to 96 Weeks)
Withdrawal of Consent (not due to AE)
|
2
|
|
Part A (Up to 96 Weeks)
Commercial Drug is Available for Participant
|
56
|
|
Part A (Up to 96 Weeks)
Other
|
1
|
|
Part B (Up to 192 Weeks)
Adverse Event
|
1
|
|
Part B (Up to 192 Weeks)
Withdrawal of Consent (not due to AE)
|
1
|
|
Part B (Up to 192 Weeks)
Commercial Drug is available for Participant
|
56
|
|
Part B (Up to 192 Weeks)
Other
|
1
|
Baseline Characteristics
The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
Baseline characteristics by cohort
| Measure |
TEZ/IVA
n=130 Participants
Part A: Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/ IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
Part B: Participants weighing \<30 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>=30 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period up to 192 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Age, Continuous
Part A
|
8.3 years
STANDARD_DEVIATION 1.7 • n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Age, Continuous
Part B
|
8.3 years
STANDARD_DEVIATION 1.7 • n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Sex: Female, Male
Part A · Female
|
67 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Sex: Female, Male
Part A · Male
|
63 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Sex: Female, Male
Part B · Female
|
35 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Sex: Female, Male
Part B · Male
|
27 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part A · Hispanic or Latino
|
4 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part A · Not Hispanic or Latino
|
119 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part A · Not collected per local regulations
|
2 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part B · Hispanic or Latino
|
3 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part B · Not Hispanic or Latino
|
52 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part B · Not collected per local regulations
|
2 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part A · White
|
125 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part A · Black or African American
|
1 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part A · Asian
|
1 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part A · Other
|
1 Participants
n=130 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part B · White
|
59 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part B · Black or African American
|
1 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part B · Asian
|
0 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
|
Race/Ethnicity, Customized
Part B · Other
|
0 Participants
n=62 Participants • The Baseline data were planned to be presented separately for Part A and Part B. Here "Number Analyzed" signifies participants who were evaluable for the specified part of the study.
|
PRIMARY outcome
Timeframe: Day 1 up to Week 100Population: Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Part A of Study 116.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=130 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants With TEAEs
|
129 Participants
|
|
Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants With SAEs
|
31 Participants
|
SECONDARY outcome
Timeframe: From Parent Study 115 Baseline at Week 96 (Study 116)Population: 115/116 Full analysis set (FAS) (TEZ/IVA group) included all enrolled participants who were randomized to the TEZ/IVA treatment group in parent Study 115 and received at least 1 dose of TEZ/IVA in Study 116 and had an eligible genotype. As pre-specified in the SAP, model-based efficacy analysis for participants from parent Study 115 was planned only for the TEZ/IVA treatment group.
The LCI2.5 index is the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting values and is calculated by dividing the sum of exhaled tidal breaths (cumulative exhaled volume (CEV)) by simultaneously measured functional residual capacity (FRC). An LCI of 7.5 and below is normal; values greater than 7.5 are abnormal. LCI is able to detect abnormalities in lung function earlier than more traditional modalities such as spirometry.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=53 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Absolute Change in Lung Clearance Index2.5 (LCI2.5) for 115/116 FAS (TEZ/IVA Group)
|
-0.95 Index
Interval -1.38 to -0.52
|
SECONDARY outcome
Timeframe: From Parent Study 113B Baseline at Week 96 (Study 116)Population: 113B/116 LCI FAS included all enrolled participants who participated in the LCI sub study in parent Study 113B and received at least 1 dose of TEZ/IVA in Study 116 and had an eligible genotype. As pre-specified in the SAP, only descriptive summary statistics were planned to be reported for the 113B/116 LCI FAS.
The LCI2.5 index is the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting values and is calculated by dividing the sum of exhaled tidal breaths (cumulative exhaled volume (CEV)) by simultaneously measured functional residual capacity (FRC). An LCI of 7.5 and below is normal; values greater than 7.5 are abnormal. LCI is able to detect abnormalities in lung function earlier than more traditional modalities such as spirometry.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=30 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Absolute Change in LCI2.5 for 113B/116 LCI FAS
|
-2.04 Index
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: From Parent Study 115 Baseline at Week 96 (Study 116)Population: 115/116 FAS (TEZ/IVA group). As pre-specified in the SAP, model-based efficacy analysis for participants from parent Study 115 was planned only for the TEZ/IVA treatment group.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=53 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Absolute Change in Sweat Chloride (SwCl) for 115/116 FAS (TEZ/IVA Group)
|
-13.8 millimole per liter (mmol/L)
Interval -17.7 to -9.9
|
SECONDARY outcome
Timeframe: From Parent Study 113B Baseline at Week 96 (Study 116)Population: 113B/116 FAS included all enrolled participants from parent Study 113B who received at least 1 dose of TEZ/IVA in Study 116 and had an eligible genotype.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=64 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Absolute Change in SwCl for 113B/116 FAS
|
-16.2 mmol/L
Interval -21.9 to -10.5
|
SECONDARY outcome
Timeframe: From Parent Study 115 Baseline at Week 96 (Study 116)Population: 115/116 FAS (TEZ/IVA group). As pre-specified in the SAP, model-based efficacy analysis for participants from parent Study 115 was planned only for the TEZ/IVA treatment group.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with CF. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=53 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score for 115/116 FAS (TEZ/IVA Group)
|
6.4 units on a scale
Interval 3.5 to 9.3
|
SECONDARY outcome
Timeframe: From Parent Study 113B Baseline at Week 96 (Study 116)Population: 113B/116 FAS.
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with CF. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=64 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Absolute Change in CFQ-R Respiratory Domain Score for 113B/116 FAS
|
6.0 units on a scale
Interval 1.1 to 10.8
|
SECONDARY outcome
Timeframe: From Parent Study 115 Baseline at Week 96 (Study 116)Population: 115/116 FAS (TEZ/IVA group). As pre-specified in the SAP, model-based efficacy analysis for participants from parent Study 115 was planned only for the TEZ/IVA treatment group.
BMI was defined as weight in kilograms (kg) divided by squared height in meters (m\^2).
Outcome measures
| Measure |
Part A: TEZ/IVA
n=53 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Absolute Change in Body Mass Index (BMI) for 115/116 FAS (TEZ/IVA Group)
|
1.25 kilogram per meter square (kg/m^2)
Interval 1.0 to 1.49
|
SECONDARY outcome
Timeframe: From Parent Study 113B Baseline at Week 96 (Study 116)Population: 113B/116 FAS.
BMI was defined as weight in kg divided by m\^2.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=64 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part A: Absolute Change in BMI for 113B/116 FAS
|
1.19 kg/m^2
Interval 0.74 to 1.64
|
SECONDARY outcome
Timeframe: Day 1 up to Week 192Population: Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Part B of Study 116.
Outcome measures
| Measure |
Part A: TEZ/IVA
n=62 Participants
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|
|
Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with TEAEs
|
53 Participants
|
|
Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
8 Participants
|
Adverse Events
Part A: TEZ/IVA
Serious events: 31 serious events
Other events: 128 other events
Deaths: 0 deaths
Part B: TEZ/IVA
Serious events: 8 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: TEZ/IVA
n=130 participants at risk
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
Part B: TEZ/IVA
n=62 participants at risk
Participants weighing \<30 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>=30 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period up to 192 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|---|
|
Psychiatric disorders
Hallucination
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
2/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
General disorders
Asthenia
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
General disorders
Pyrexia
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Bacterial disease carrier
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Chronic sinusitis
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Device related sepsis
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Gastroenteritis
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
11.5%
15/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Influenza
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Pertussis
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Septic shock
|
0.00%
0/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Sinusitis
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Alanine aminotransferase increased
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Bacterial test positive
|
2.3%
3/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Pulmonary function test decreased
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Stenotrophomonas test positive
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Psychiatric disorders
Anxiety disorder
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Psychiatric disorders
Personality change
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
3.2%
2/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.77%
1/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
Other adverse events
| Measure |
Part A: TEZ/IVA
n=130 participants at risk
Participants weighing \<40 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>= 40 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
Part B: TEZ/IVA
n=62 participants at risk
Participants weighing \<30 kg at Day 1 received TEZ 50 mg qd/IVA 75 mg q12h and the participants weighing \>=30 kg at Day 1 received TEZ 100 mg qd/IVA 150 mg q12h in the treatment period up to 192 weeks. Doses were adjusted upward for changes in body weight and/or age.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
15.4%
20/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
9.7%
6/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
1.6%
1/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Constipation
|
7.7%
10/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
6.5%
4/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Nausea
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
4.8%
3/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Gastrointestinal disorders
Vomiting
|
16.2%
21/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
8.1%
5/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
General disorders
Fatigue
|
5.4%
7/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
General disorders
Pyrexia
|
20.0%
26/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
4.8%
3/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Bacterial disease carrier
|
5.4%
7/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
9.7%
6/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
COVID-19
|
0.00%
0/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
24.2%
15/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Ear infection
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
3.2%
2/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Gastroenteritis
|
6.9%
9/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
3.2%
2/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
43.8%
57/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
16.1%
10/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Influenza
|
10.0%
13/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Nasopharyngitis
|
18.5%
24/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
16.1%
10/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Otitis media
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
6.5%
4/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Pharyngitis
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Pharyngitis streptococcal
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Rhinitis
|
8.5%
11/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
6.5%
4/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Tonsillitis
|
1.5%
2/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
6.5%
4/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.8%
31/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
16.1%
10/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.7%
10/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
4.8%
3/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Alanine aminotransferase increased
|
9.2%
12/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
3.2%
2/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
6.2%
8/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
3.2%
2/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Bacterial test positive
|
14.6%
19/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
12.9%
8/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Forced expiratory volume decreased
|
5.4%
7/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
11.3%
7/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Pseudomonas test positive
|
8.5%
11/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
3.2%
2/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Investigations
Staphylococcus test positive
|
2.3%
3/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
6.5%
4/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Nervous system disorders
Headache
|
15.4%
20/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
12.9%
8/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
56.2%
73/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
24.2%
15/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
4/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
6.5%
4/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
18.5%
24/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
3.2%
2/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
5.4%
7/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
4.8%
3/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.5%
24/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
9.7%
6/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.9%
22/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
9.7%
6/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.8%
14/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
4.8%
3/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
7/130 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
0.00%
0/62 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, and up to Week 192 for Part B)
Safety Set included all participants who were enrolled and received at least 1 dose of TEZ/IVA in Study 116.MedDRA version 23.1 applied for Part A, MedDRA version 26.1 applied for Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER