Trial Outcomes & Findings for A Study Evaluating the Long-term Safety of VX-445 Combination Therapy (NCT NCT04043806)
NCT ID: NCT04043806
Last Updated: 2023-07-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
458 participants
Primary outcome timeframe
From Baseline through Week 100
Results posted on
2023-07-06
Participant Flow
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B.
A total 458 participants were enrolled from the parent study VX17-659-105 (NCT03447262). One participant was enrolled but did not receive any dose in this study.
Participant milestones
| Measure |
ELX/TEZ/IVA
Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.
Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|
|
Overall Study
STARTED
|
458
|
|
Overall Study
Safety Set
|
457
|
|
Overall Study
COMPLETED
|
412
|
|
Overall Study
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
ELX/TEZ/IVA
Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.
Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|
|
Overall Study
Commercial drug is available for participants
|
13
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Other
|
12
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Other non-compliance
|
2
|
|
Overall Study
Withdrawal of Consent (not due to AE)
|
8
|
|
Overall Study
Never Dosed
|
1
|
Baseline Characteristics
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
Baseline characteristics by cohort
| Measure |
ELX/TEZ/IVA
n=457 Participants
Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks.
Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
255 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
437 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not collected per local regulations
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
445 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline through Week 100Population: Safety set for included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
ELX/TEZ/IVA
n=457 Participants
Participants received ELX 200 mg qd/TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 96 weeks in Part A.
|
|---|---|
|
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
|
435 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
|
75 participants
|
Adverse Events
Part A: ELX/TEZ/IVA
Serious events: 75 serious events
Other events: 404 other events
Deaths: 0 deaths
Part B: ELX/TEZ/IVA
Serious events: 4 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: ELX/TEZ/IVA
n=457 participants at risk
Participants received ELX 200 mg qd, TEZ 100 mg qd, and IVA 150 mg q12h in the treatment period for 96 weeks.
|
Part B: ELX/TEZ/IVA
n=66 participants at risk
Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
0.44%
2/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
0.66%
3/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Duodenitis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Gastritis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.44%
2/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Proctitis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
2/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Hypothermia
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Pyrexia
|
0.44%
2/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Vascular device occlusion
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Abdominal abscess
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Bronchitis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
COVID-19
|
0.44%
2/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Catheter site infection
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Herpes simplex pharyngitis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
6.8%
31/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Influenza
|
0.44%
2/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Nasopharyngitis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Pneumonia
|
1.5%
7/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Sinusitis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Injury, poisoning and procedural complications
Stoma site discharge
|
0.00%
0/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Nervous system disorders
Piriformis syndrome
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Nervous system disorders
Seizure
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Confusional state
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Conversion disorder
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Substance-induced mood disorder
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Psychiatric disorders
Suicidal ideation
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.44%
2/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.44%
2/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.66%
3/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.22%
1/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
Other adverse events
| Measure |
Part A: ELX/TEZ/IVA
n=457 participants at risk
Participants received ELX 200 mg qd, TEZ 100 mg qd, and IVA 150 mg q12h in the treatment period for 96 weeks.
|
Part B: ELX/TEZ/IVA
n=66 participants at risk
Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.6%
30/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
3.0%
2/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.2%
33/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Nausea
|
8.8%
40/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
3.0%
2/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
25/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
9.1%
6/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Fatigue
|
10.1%
46/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
6.1%
4/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Pain
|
5.3%
24/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
General disorders
Pyrexia
|
13.8%
63/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Immune system disorders
Immunisation reaction
|
9.2%
42/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
COVID-19
|
6.6%
30/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
27.3%
18/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
23.4%
107/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
18.2%
12/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Nasopharyngitis
|
13.3%
61/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Sinusitis
|
6.8%
31/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
4.5%
3/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.5%
71/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
15.2%
10/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
10.1%
46/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Alanine aminotransferase increased
|
8.5%
39/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
4.5%
3/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
6.8%
31/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
4.5%
3/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Investigations
Blood creatine phosphokinase increased
|
8.5%
39/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
27/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
3.0%
2/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.8%
31/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
23/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Nervous system disorders
Headache
|
20.1%
92/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
7.6%
5/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.9%
114/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
9.1%
6/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
26/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.0%
41/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
7.6%
5/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.4%
52/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
13.3%
61/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
27/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
5.3%
24/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.9%
36/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
3.0%
2/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.7%
26/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
14.7%
67/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
0.00%
0/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
26/457 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
1.5%
1/66 • Day 1 Through Safety Follow-up Visit (up to Week 100 for Part A, up to Week 52 for Part B)
The study was conducted as a single part study (Part A) in countries including United States (US) with commercially-available ELX/TEZ/IVA. The regional protocol for countries without commercially-available ELX/TEZ/IVA was amended so that participants in these countries had the opportunity to participate for up to an additional 48 weeks in Part B. The adverse events data has been reported for both the parts separately. MedDRA 25.0 applied for Part A and MedDRA 25.1 applied for Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place