Trial Outcomes & Findings for A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation (NCT NCT03125395)
NCT ID: NCT03125395
Last Updated: 2020-08-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
57 participants
Primary outcome timeframe
Day 1 up to Week 98
Results posted on
2020-08-07
Participant Flow
This study was planned to have 2 cohorts: Treatment Cohort and Observational Cohort. Only the Treatment Cohort is presented in results as there were no participants enrolled in the Observational Cohort.
This study was conducted in participants with cystic fibrosis (CF) aged 2 years and older who participated in parent study VX15-809-115 Part B (NCT02797132).
Participant milestones
| Measure |
LUM/IVA
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
Study 115B FAS
|
60
|
|
Overall Study
Study 116 FAS
|
57
|
|
Overall Study
Study 116 LCI Substudy Set
|
31
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
LUM/IVA
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal of consent (not due to AE)
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Commercial drug is available
|
5
|
Baseline Characteristics
A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Baseline characteristics by cohort
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Age, Continuous
|
43.2 months
STANDARD_DEVIATION 12.17 • n=99 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Week 98Population: Study 116 safety set included all participants dosed in study 115B who were exposed to any amount of study drug in current study 116 treatment cohort.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Safety as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with AEs
|
56 participants
|
|
Safety as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
15 participants
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 Full Analysis Set (FAS) included all participants who were enrolled and exposed to any amount of study drug in current study 116.
Sweat samples were collected using an approved collection device.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Sweat Chloride
|
-29.6 millimole per liter (mmol/L)
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 FAS.
BMI was defined as weight in kilogram (kg) divided by height in square meter (m\^2).
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Body Mass Index (BMI)
|
0.30 kg/m^2
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 FAS.
BMI was defined as weight in kilograms divided by height in m\^2. z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in BMI-for-age Z-score
|
0.27 z-score
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 FAS.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Weight
|
6.0 kg
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 FAS.
Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Weight-for-age Z-score
|
0.23 z-score
Standard Error 0.56
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 FAS.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change From Baseline in Stature (Height)
|
16.1 centimeter
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 FAS.
Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Stature-for-age Z-score
|
0.07 z-score
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline through Week 96Population: Study 115B FAS included all participants who were enrolled and exposed to any amount of study drug in parent study 115B
Pulmonary exacerbation was defined as new or changed treatment with oral, inhaled, or intravenous antibiotics and fulfillment of pre-specified protocol-defined criteria.
Outcome measures
| Measure |
LUM/IVA
n=60 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Time-to-first Pulmonary Exacerbation
|
600.0 days
Interval 98.0 to
Upper limit of inter-quartile range could not be estimated because less than 75% of participants had events.
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline through Week 96Population: Study 115B FAS.
Pulmonary exacerbation was defined as new or changed treatment with oral, inhaled, or intravenous antibiotics and fulfillment of pre-specified protocol-defined criteria.
Outcome measures
| Measure |
LUM/IVA
n=60 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Number of Pulmonary Exacerbations (PEx)
|
82 pulmonary exacerbation events
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline through Week 96Population: Study 115B FAS.
Outcome measures
| Measure |
LUM/IVA
n=60 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Number of Cystic Fibrosis (CF) Related Hospitalizations
|
28 hospitalizations
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 FAS.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Fecal Elastase-1 (FE-1) Levels
|
132.6 microgram per gram (mcg/g)
Standard Deviation 174.2
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 FAS.
Outcome measures
| Measure |
LUM/IVA
n=57 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Immunoreactive Trypsinogen (IRT) Serum Levels
|
-108.5 nanogram per milliliter (ng/mL)
Standard Deviation 306.6
|
SECONDARY outcome
Timeframe: Week 96Population: Study 116 FAS. Here "Overall Number of Participants Analyzed" signifies those participants who were evaluated for this outcome at Week 96.
Following microbial tests were performed: Burkholderia, Methicillin Resistant Staphylococcus Aureus (MRSA), Methicillin Susceptible Staphylococcus Aureus (MSSA), Pseudomonas Aeruginosa Mucoid (P. Aeruginosa Mucoid), P. Aeruginosa Non-Mucoid, P. Aeruginosa Small Colony Variant and Stenotrophomonas Maltophilia.
Outcome measures
| Measure |
LUM/IVA
n=46 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
Burkholderia (Positive)
|
0 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
Burkholderia (Negative)
|
46 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
MRSA (Positive)
|
4 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
MRSA (Negative)
|
42 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
MSSA (Positive)
|
15 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
MSSA (Negative)
|
31 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
P. Aeruginosa Mucoid (Positive)
|
0 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
P. Aeruginosa Mucoid (Negative)
|
46 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
P. Aeruginosa Non-Mucoid (Positive)
|
1 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
P. Aeruginosa Non-Mucoid (Negative)
|
45 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
P. Aeruginosa Small Colony Variant (Positive)
|
0 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
P. Aeruginosa Small Colony Variant (Negative)
|
46 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
Stenotrophomonas Maltophilia (Positive)
|
2 participants
|
|
Number of Participants With Microbiology Culture Status (Positive or Negative)
Stenotrophomonas Maltophilia (Negative)
|
44 participants
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 LCI substudy set included all participants who signed the informed consent/assent to the optional LCI substudy and were enrolled and exposed to any amount of study drug in current study 116.
LCI 2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value.
Outcome measures
| Measure |
LUM/IVA
n=31 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Lung Clearance Index (LCI) 2.5
|
-0.20 lung clearance index
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: From Parent Study 115B Baseline at Week 96Population: Study 116 LCI substudy set.
LCI 5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value.
Outcome measures
| Measure |
LUM/IVA
n=31 Participants
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Absolute Change in Lung Clearance Index (LCI) 5.0
|
0.11 lung clearance index
Standard Deviation 0.65
|
Adverse Events
LUM/IVA
Serious events: 15 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
LUM/IVA
n=57 participants at risk
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Infections and infestations
Gastritis viral
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Infections and infestations
Gastroenteritis adenovirus
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Gastrointestinal disorders
Haematemesis
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Gastrointestinal disorders
Pancreatitis
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Infections and infestations
Appendicitis
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Infections and infestations
Chronic sinusitis
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Infections and infestations
Gastroenteritis viral
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
10.5%
6/57 • Day 1 up to Week 98
|
|
Infections and infestations
Pneumonia
|
3.5%
2/57 • Day 1 up to Week 98
|
|
Infections and infestations
Respiratory tract infection viral
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Investigations
Aspartate aminotransferase increased
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Metabolism and nutrition disorders
Weight gain poor
|
1.8%
1/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
1.8%
1/57 • Day 1 up to Week 98
|
Other adverse events
| Measure |
LUM/IVA
n=57 participants at risk
LUM/IVA granules or tablets were administered orally every 12 hours (Participants aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Participants ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
|
|---|---|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Gastrointestinal disorders
Abdominal pain
|
12.3%
7/57 • Day 1 up to Week 98
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.0%
4/57 • Day 1 up to Week 98
|
|
Gastrointestinal disorders
Constipation
|
12.3%
7/57 • Day 1 up to Week 98
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
6/57 • Day 1 up to Week 98
|
|
Gastrointestinal disorders
Vomiting
|
29.8%
17/57 • Day 1 up to Week 98
|
|
General disorders
Fatigue
|
8.8%
5/57 • Day 1 up to Week 98
|
|
General disorders
Pyrexia
|
40.4%
23/57 • Day 1 up to Week 98
|
|
General disorders
Vessel puncture site pain
|
7.0%
4/57 • Day 1 up to Week 98
|
|
Infections and infestations
Conjunctivitis
|
7.0%
4/57 • Day 1 up to Week 98
|
|
Infections and infestations
Ear infection
|
21.1%
12/57 • Day 1 up to Week 98
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
17.5%
10/57 • Day 1 up to Week 98
|
|
Infections and infestations
Influenza
|
7.0%
4/57 • Day 1 up to Week 98
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
8/57 • Day 1 up to Week 98
|
|
Infections and infestations
Otitis media
|
12.3%
7/57 • Day 1 up to Week 98
|
|
Infections and infestations
Pharyngitis streptococcal
|
10.5%
6/57 • Day 1 up to Week 98
|
|
Infections and infestations
Pneumonia
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Infections and infestations
Sinusitis
|
21.1%
12/57 • Day 1 up to Week 98
|
|
Infections and infestations
Upper respiratory tract infection
|
22.8%
13/57 • Day 1 up to Week 98
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.0%
4/57 • Day 1 up to Week 98
|
|
Investigations
Alanine aminotransferase increased
|
17.5%
10/57 • Day 1 up to Week 98
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
5/57 • Day 1 up to Week 98
|
|
Investigations
Forced expiratory volume decreased
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.0%
4/57 • Day 1 up to Week 98
|
|
Investigations
Pseudomonas test positive
|
15.8%
9/57 • Day 1 up to Week 98
|
|
Investigations
Staphylococcus test positive
|
21.1%
12/57 • Day 1 up to Week 98
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.5%
6/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
82.5%
47/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
7.0%
4/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
43.9%
25/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discharge discolouration
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.5%
10/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
8.8%
5/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
31.6%
18/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
8.8%
5/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.3%
3/57 • Day 1 up to Week 98
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
3/57 • Day 1 up to Week 98
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place