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Trial record 1 of 1 for:    63623872FLZ2002
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A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult, and Elderly Hospitalized Participants With Influenza A Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02532283
Recruitment Status : Completed
First Posted : August 25, 2015
Results First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Influenza A Virus
Interventions Drug: JNJ-63623872
Drug: Placebo
Drug: Oseltamivir
Enrollment 102
Recruitment Details  
Pre-assignment Details In total, 102 participants were randomized. 3 participants were randomized but not treated due to withdrawal of consent before treatment start. Therefore, the Safety Set, comprising all participants who received at least 1 dose of study drug(s), consisted of 99 participants.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value. Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Period Title: Overall Study
Started 64 35
Full Analysis Set 63 32
Completed 55 30
Not Completed 9 5
Reason Not Completed
Adverse Event             0             1
Death             1             0
Lost to Follow-up             0             1
Withdrawal by Subject             8             3
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg Total
Hide Arm/Group Description Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value. Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value. Total of all reporting groups
Overall Number of Baseline Participants 64 35 99
Hide Baseline Analysis Population Description
Safety analysis set was defined as all participants who received at least 1 dose of study drug and analyzed as treated.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 35 participants 99 participants
58.1  (16.06) 57.2  (13.71) 57.8  (15.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 35 participants 99 participants
Female
27
  42.2%
18
  51.4%
45
  45.5%
Male
37
  57.8%
17
  48.6%
54
  54.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 35 participants 99 participants
Hispanic or Latino
8
  12.5%
2
   5.7%
10
  10.1%
Not Hispanic or Latino
55
  85.9%
32
  91.4%
87
  87.9%
Unknown or Not Reported
1
   1.6%
1
   2.9%
2
   2.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 35 participants 99 participants
American Indian or Alaska Native
1
   1.6%
0
   0.0%
1
   1.0%
Asian
5
   7.8%
7
  20.0%
12
  12.1%
Black or African American
6
   9.4%
7
  20.0%
13
  13.1%
More than one race
0
   0.0%
1
   2.9%
1
   1.0%
Other
2
   3.1%
1
   2.9%
3
   3.0%
Unknown or Not Reported
2
   3.1%
0
   0.0%
2
   2.0%
White
48
  75.0%
19
  54.3%
67
  67.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 35 participants 99 participants
BELGIUM
3
   4.7%
0
   0.0%
3
   3.0%
FRANCE
6
   9.4%
2
   5.7%
8
   8.1%
GERMANY
0
   0.0%
2
   5.7%
2
   2.0%
HONG KONG
0
   0.0%
1
   2.9%
1
   1.0%
MALAYSIA
3
   4.7%
4
  11.4%
7
   7.1%
NETHERLANDS
3
   4.7%
1
   2.9%
4
   4.0%
SINGAPORE
1
   1.6%
0
   0.0%
1
   1.0%
SPAIN
16
  25.0%
7
  20.0%
23
  23.2%
SWEDEN
8
  12.5%
4
  11.4%
12
  12.1%
TURKEY
6
   9.4%
3
   8.6%
9
   9.1%
UNITED STATES
18
  28.1%
11
  31.4%
29
  29.3%
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Pimodivir
Hide Description Cmax is the maximum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to less than or equal to [<=] 85 years and 18 to <=64 years).
Time Frame Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this outcome measure (OM).
Arm/Group Title Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) Non-elderly Adults (18 to <=64 Years)
Hide Arm/Group Description:
Participants received pimodivir 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Participants received pimodivir 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Overall Number of Participants Analyzed 15 20
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
5933  (4427) 5378  (3888)
2.Primary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of Pimodivir
Hide Description Cmin is the minimum observed plasma concentration. As per planned analysis, results are presented by age groups (65 to <= 85 years and 18 to <=64 years).
Time Frame Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
Arm/Group Title Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) Non-elderly Adults (18 to <=64 Years)
Hide Arm/Group Description:
Participants received pimodivir 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Participants received pimodivir 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Overall Number of Participants Analyzed 15 21
Mean (Standard Deviation)
Unit of Measure: ng/mL
738  (892) 507  (414)
3.Primary Outcome
Title Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir
Hide Description AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours after dosing of pimodivir. As per planned analysis, results are presented by age groups (65 to <= 85 years and 18 to <=64 years).
Time Frame Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants from whom sufficient concentration data were available to facilitate derivation of at least one PK parameter. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
Arm/Group Title Elderly Adults (65 to Less Than or Equal to [<=] 85 Years) Non-elderly Adults (18 to <=64 Years)
Hide Arm/Group Description:
Participants received pimodivir 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Participants received pimodivir 600 mg tablets and oseltamivir 75 mg capsules orally twice daily for 7 days.
Overall Number of Participants Analyzed 15 20
Mean (Standard Deviation)
Unit of Measure: nanogram hours per milliliter (ng*h/mL)
27386  (25191) 20101  (11063)
4.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs)
Hide Description An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with treatment and therefore can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with use of a medicinal product, whether or not related to that medicinal product. TEAEs were defined as AEs that were reported or worsened on after start of study drug(s) dosing through safety follow-up visit. A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least one dose of study drug(s) and were analyzed by drug received.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 64 35
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
48
  75.0%
25
  71.4%
TESAEs
11
  17.2%
4
  11.4%
5.Secondary Outcome
Title Time to Influenza A Viral Negativity
Hide Description Time to influenza A viral negativity was determined based on quantitative reverse transcription polymerase chain reaction (qRT-PCR). A participant was considered influenza A viral negative at the time point that the first negative nasal midturbinate (MT) swab was recorded (in days). Viral Load Limit of detection (LOD) = 2.18 log10 viral particles per milliliter (vp/mL). Results less than (<) limit of quantification (LOQ) and greater than (>) LOD (target detected) are imputed with 2.12 log10 vp/mL, results <LOD (target not detected) are imputed with 0 log10 vp/mL.
Time Frame Up to 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS) was defined as all randomly assigned participants who received at least 1 dose of study drug and who had a confirmed infection with influenza A.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 63 32
Median (95% Confidence Interval)
Unit of Measure: Days
9.53
(8.55 to 12.68)
9.74
(6.67 to 12.99)
6.Secondary Outcome
Title Influenza Viral Load Over Time
Hide Description Influenza viral load over time (Log 10 viral particles per milliliter [vp/mL]) was measured by qRT-PCR. Viral Load LOD = 2.18 log10 vp/mL. Results < LOQ and > LOD (target detected) are imputed with 2.12 log10 vp/mL and results <LOD (target not detected) are imputed with 0 log10 vp/mL.
Time Frame Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 58 30
Mean (Standard Deviation)
Unit of Measure: Log 10 vp/mL
Baseline Number Analyzed 58 participants 30 participants
5.45  (1.737) 5.90  (1.513)
Day 1 Number Analyzed 4 participants 1 participants
6.40  (0.757) 4.43 [1]   (NA)
Day 2 Number Analyzed 57 participants 28 participants
4.75  (1.290) 4.63  (1.757)
Day 3 Number Analyzed 45 participants 24 participants
3.83  (1.310) 3.98  (1.924)
Day 4 Number Analyzed 34 participants 15 participants
3.00  (1.486) 3.14  (1.806)
Day 5 Number Analyzed 55 participants 28 participants
2.57  (1.716) 2.60  (1.803)
Day 6 Number Analyzed 14 participants 6 participants
2.07  (1.454) 2.18  (2.457)
Day 7 Number Analyzed 14 participants 5 participants
1.95  (1.478) 2.38  (2.212)
Day 8 Number Analyzed 55 participants 20 participants
1.82  (1.709) 1.43  (1.648)
Day 9 Number Analyzed 7 participants 1 participants
1.51  (1.034) 0.00 [1]   (NA)
Day 10 Number Analyzed 54 participants 23 participants
1.39  (1.676) 0.99  (1.295)
Day 11 Number Analyzed 6 participants 1 participants
0.42  (1.017) 0.00 [1]   (NA)
Day 12 Number Analyzed 2 participants 0 participants
1.06  (1.499)
Day 13 Number Analyzed 2 participants 0 participants
1.06  (1.499)
Day 14 Number Analyzed 51 participants 22 participants
1.05  (1.636) 0.20  (0.646)
[1]
Here, NA indicates that data was not available as standard deviation could not be calculated for a single participant.
7.Secondary Outcome
Title Rate of Decline in Viral Load
Hide Description Rate of decline in viral load (Log10 viral particles per milliliter per day [log10 vp/mL/day]) during treatment was measured by qRT-PCR. Viral Load Limit of quantification (LOQ) = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results < LOQ and greater than > LOD (target detected) are imputed with 2.12 log10 vp/mL. Results <LOD (target not detected) are imputed with 0 log10 vp/mL.
Time Frame Up to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 63 32
Median (95% Confidence Interval)
Unit of Measure: Log10 vp/mL/day
-0.35
(-0.39 to -0.30)
-0.42
(-0.49 to -0.35)
8.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) of Viral Load
Hide Description Viral load AUC was determined by qRT-PCR assay of nasal swabs. Viral Load LOQ = 2.18 log10 vp/mL, LOD = 2.05 log10 vp/mL. Results <LOQ and >LOD (target detected) are imputed with 2.12 log10 vp/mL. Results <LOD (target not detected) are imputed with 0 log10 vp/mL.
Time Frame Baseline up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 63 32
Mean (95% Confidence Interval)
Unit of Measure: Days*vp/mL
22.8
(20.4 to 25.1)
22.1
(19.0 to 25.2)
9.Secondary Outcome
Title Percentage of Participants With Influenza Complications
Hide Description Percentage of participants with following Influenza Complications: bacterial pneumonia (culture confirmed where possible), bacterial superinfections, respiratory failure, pulmonary disease (example, asthma, chronic obstructive pulmonary disease [COPD]), cardiovascular and cerebrovascular disease (example, myocardial infarction, congestive heart failure [CHF], arrhythmia, stroke) and all complications were reported.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 63 32
Measure Type: Number
Unit of Measure: Percentage of participants
All complications 7.9 15.6
Bacterial pneumonia 0 0
Bacterial superinfections 1.6 3.1
Respiratory failure 1.6 0
Pulmonary disease 3.2 6.3
Cardiovascular and Cerebrovascular disease 1.6 0
10.Secondary Outcome
Title Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score
Hide Description FLU-PRO assesses 32 influenza symptoms in each of the following body areas (domains): Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal and Body/Systemic . Participants rate each symptom on a 5-point ordinal scale, with higher scores indicating a more frequent sign or symptom. For 27 of the items, the scale is as follows: 0 ("Not at all"), 1 ("A little bit"), 2 ("Somewhat"), 3 ("Quite a bit"), and 4 ("Very much"). For 5 items, severity is assessed in terms of numerical frequency, that is (i.e), vomiting or diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing, and coughed up mucus or phlegm evaluated on a scale from 0 ("Never") to 4 ("Always").The FLU-PRO total score is computed as a mean score across all 32 items comprising the instrument. Total scores can range from 0 (symptom free) to 4 (very severe symptoms).
Time Frame Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, and 33
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 38 32
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 1 Number Analyzed 20 participants 16 participants
-0.08  (0.247) -0.11  (0.349)
Day 2 Number Analyzed 35 participants 20 participants
-0.48  (0.644) -0.33  (0.798)
Day 3 Number Analyzed 38 participants 22 participants
-0.60  (0.624) -0.52  (0.641)
Day 4 Number Analyzed 35 participants 19 participants
-0.71  (0.702) -0.56  (0.625)
Day 5 Number Analyzed 33 participants 17 participants
-0.76  (0.689) -0.67  (0.643)
Day 6 Number Analyzed 33 participants 17 participants
-0.85  (0.692) -0.75  (0.659)
Day 7 Number Analyzed 33 participants 17 participants
-0.87  (0.738) -0.69  (0.623)
Day 8 Number Analyzed 33 participants 18 participants
-0.89  (0.729) -0.80  (0.764)
Day 9 Number Analyzed 31 participants 20 participants
-0.93  (0.764) -0.84  (0.732)
Day 10 Number Analyzed 32 participants 20 participants
-0.91  (0.723) -0.81  (0.743)
Day 11 Number Analyzed 28 participants 18 participants
-0.87  (0.756) -0.76  (0.534)
Day 12 Number Analyzed 29 participants 18 participants
-0.87  (0.725) -0.89  (0.695)
Day 13 Number Analyzed 28 participants 20 participants
-0.93  (0.702) -0.94  (0.650)
Day 14 Number Analyzed 29 participants 19 participants
-0.85  (0.613) -0.92  (0.670)
Day 15 Number Analyzed 25 participants 15 participants
-0.88  (0.630) -0.90  (0.724)
Day 16 Number Analyzed 23 participants 14 participants
-0.84  (0.588) -0.90  (0.762)
Day 17 Number Analyzed 22 participants 15 participants
-0.98  (0.690) -0.97  (0.774)
Day 18 Number Analyzed 19 participants 15 participants
-1.06  (0.753) -1.00  (0.868)
Day 19 Number Analyzed 21 participants 13 participants
-1.06  (0.749) -1.05  (0.880)
Day 20 Number Analyzed 21 participants 15 participants
-1.03  (0.710) -1.03  (0.847)
Day 21 Number Analyzed 22 participants 16 participants
-1.00  (0.701) -0.98  (0.849)
Day 22 Number Analyzed 18 participants 15 participants
-1.02  (0.789) -0.92  (0.690)
Day 23 Number Analyzed 21 participants 14 participants
-1.11  (0.858) -0.96  (0.731)
Day 24 Number Analyzed 19 participants 11 participants
-0.87  (0.534) -0.91  (0.580)
Day 25 Number Analyzed 17 participants 11 participants
-0.94  (0.659) -0.85  (0.661)
Day 26 Number Analyzed 18 participants 11 participants
-0.86  (0.755) -0.87  (0.742)
Day 27 Number Analyzed 15 participants 8 participants
-1.02  (0.745) -0.74  (0.734)
Day 28 Number Analyzed 12 participants 7 participants
-0.60  (0.505) -0.82  (0.675)
Day 29 Number Analyzed 2 participants 2 participants
-1.13  (0.354) -1.63  (0.398)
Day 30 Number Analyzed 2 participants 0 participants
-0.61  (0.552)
Day 31 Number Analyzed 1 participants 0 participants
-0.75 [1]   (NA)
Day 32 Number Analyzed 2 participants 0 participants
-0.61  (0.420)
Day 33 Number Analyzed 1 participants 0 participants
-0.94 [1]   (NA)
[1]
Here, NA indicates that data was not available as standard deviation could not be calculated for a single participant.
11.Secondary Outcome
Title Time to Improvement of Vital Signs
Hide Description Time to improvement of vital signs was defined as the time from first study treatment to when at least 4 of 5 symptoms (temperature, blood oxygen saturation, heart rate, systolic blood pressure, and respiration rate) had recovered, including normalization of temperature and blood oxygen saturation. Resolution criteria for vital signs: for Temperature: oral temperature less than or equal to (<=) 36.5 degree Celsius (C) for elderly and <=37.2 C for adults; for oxygen saturation: greater than or equal to (>=) 92 percent (%) on room air without supplemental oxygen; for respiratory rate: <= 24 per minutes; for heart rate: <= 100 per minutes and for systolic blood pressure: >= 90 millimeters of mercury (mmHg).
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 60 28
Median (95% Confidence Interval)
Unit of Measure: Hours
169.92 [1] 
(46.63 to NA)
69.90 [2] 
(35.83 to NA)
[1]
Here 'NA' indicates that the upper limit of 95% confidence interval (CI) was not estimable due to less number of events.
[2]
Here 'NA' indicates that the upper limit of 95% CI was not estimable due to less number of events.
12.Secondary Outcome
Title Time to Improvement of Respiratory Status
Hide Description The time to improvement of respiratory status was defined as the time from first study treatment until the first assessment of a successive series of 3 recording where normalization of blood oxygen saturation and respiration rate occurred at respiration rate <=24 per minutes).
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 60 28
Median (95% Confidence Interval)
Unit of Measure: Hours
33.53
(21.33 to 241.92)
40.57 [1] 
(22.75 to NA)
[1]
Here 'NA' indicates that the upper limit of 95% CI was not estimable due to less number of events.
13.Secondary Outcome
Title Percentage of Participants With Clinical Outcome Based on Ordinal Scale
Hide Description The ordinal scale was used to assess participant's clinical outcome. It consists of 6 categories or clinical states that are exhaustive, mutually exclusive, and ordered, where 1- Death, 2- Admitted to intensive care unit (ICU) or mechanically ventilated/ extracorporeal membrane oxygenation (ECMO), 3- Non-ICU plus supplemental oxygen, 4- Non-ICU plus no supplemental oxygen, 5- Not hospitalized, but unable to continue activity, 6- Not hospitalized (NH) and continues activities.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 62 31
Measure Type: Number
Unit of Measure: Percentage of Participants
Day 8: NH and Continues Activities 40.3 29.0
Day 8: NH, but Unable to Continue Activity 27.4 45.2
Day 8: Non-ICU+No Supplemental Oxygen 14.5 6.5
Day 8: Non-ICU+Supplemental Oxygen 8.1 3.2
Day 8: Death 1.6 0
Day 8: Missing 8.1 16.1
14.Secondary Outcome
Title Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir
Hide Description Number of participants with emergence (from baseline) of drug resistance mutations detected by genotype or phenotype were reported.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 63 32
Measure Type: Count of Participants
Unit of Measure: Participants
Emergence of Pimodivir Mutation
0
   0.0%
0
   0.0%
Emergence of OST Mutation
0
   0.0%
1
   3.1%
15.Secondary Outcome
Title Time to Return to Premorbid Functional Status
Hide Description Time to return to premorbid functional status (time to return usual activities) was defined as time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 7 (Have you returned to your usual activities today?).
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 60 32
Median (95% Confidence Interval)
Unit of Measure: Hours
142.85
(83.27 to 220.15)
154.83
(74.97 to 386.52)
16.Secondary Outcome
Title Time to Hospital Discharge
Hide Description Time to hospital discharge was calculated from the date of first study drug intake during hospitalization up to date of discharge.
Time Frame Up to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 63 32
Median (95% Confidence Interval)
Unit of Measure: Days
4.00
(3.00 to 5.00)
4.00
(3.00 to 4.00)
17.Secondary Outcome
Title Time to Return to Usual Health
Hide Description Time to return to usual health was defined as the time in hours from the first dose of investigational product till the first one of 2 successive cases where the response is 'Yes' on FLU-PRO additional question 9 (Have you returned to your health today?).
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 60 32
Median (95% Confidence Interval)
Unit of Measure: Hours
217.05
(122.03 to 291.42)
338.83 [1] 
(107.40 to NA)
[1]
Here 'NA' indicates that the upper limit of 95% CI was not estimable due to less number of events.
18.Secondary Outcome
Title Time to Significant Reduction in FLU-PRO Influenza Symptom Severity
Hide Description Time to significant reduction in influenza symptom severity (mild/none) is time from first dose of investigational drug until first of 2 successive recordings in which total score for each of 2 recordings is lower or equal to 1 and all domain scores is lower or equal to 1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on 5-point scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed in terms of numerical frequency, i.e, vomiting/diarrhea (0 times, 1 time, 2 times, 3 times, or 4 or more times); with frequency of sneezing, coughing and coughed up mucus or phlegm evaluated on scale from 0=Never to 4=Always. FLU-PRO total score is computed as mean score across all 32 items and ranges from 0 (symptom free) to 4 (very severe symptoms).
Time Frame Up to Day 33
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 60 32
Median (95% Confidence Interval)
Unit of Measure: Hours
118.45
(82.33 to 171.93)
218.72
(94.70 to 275.58)
19.Secondary Outcome
Title Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms)
Hide Description Percentage of participants with significant reduction in influenza symptom severity was defined as time from first dose of investigational product until first of 2 successive recordings in which FLU-PRO total score for each of 2 recordings <= to 1 and all FLU-PRO domain scores is <=1. FLU-PRO assesses 32 influenza symptoms in body areas (domains): Nose, throat, eyes, chest, gastrointestinal, body. Participants rate each symptom on a 5-point ordinal scale, with higher scores indicates more frequent symptom. For 27 of items, scale is as follows: 0 (Not at all), 1 (A little bit), 2 (Somewhat), 3 (Quite a bit), 4 (Very much). For 5 items, severity is assessed as numerical frequency i.e, vomiting or diarrhea (0-4 or more times); with frequency of sneezing, coughing, coughed up mucus or phlegm evaluated on a scale from 0 (Never)-4 (Always). FLU-PRO total score is computed as a mean score across all 32 items comprising instrument and ranges from 0 (symptom free) to 4 (very severe symptoms).
Time Frame Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32 and 33
Hide Outcome Measure Data
Hide Analysis Population Description
FAS was defined as all randomly assigned participants who received at least 1 dose of study drug and who have a confirmed infection with influenza A. Here, N (number of participants analyzed) signifies number of participants evaluable for this OM and 'n' signifies number of participants evaluable at specified time points.
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description:
Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value.
Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
Overall Number of Participants Analyzed 55 30
Measure Type: Number
Unit of Measure: Percentage of participants
Day 1 Number Analyzed 32 participants 22 participants
9.4 18.2
Day 2 Number Analyzed 51 participants 26 participants
37.3 34.6
Day 3 Number Analyzed 55 participants 30 participants
36.4 26.7
Day 4 Number Analyzed 50 participants 26 participants
42.0 38.5
Day 5 Number Analyzed 50 participants 24 participants
54.0 37.5
Day 6 Number Analyzed 49 participants 25 participants
59.2 40.0
Day 7 Number Analyzed 49 participants 23 participants
55.1 34.8
Day 8 Number Analyzed 51 participants 25 participants
62.7 32.0
Day 9 Number Analyzed 50 participants 26 participants
76.0 38.5
Day 10 Number Analyzed 51 participants 26 participants
76.5 53.8
Day 11 Number Analyzed 47 participants 22 participants
70.2 59.1
Day 12 Number Analyzed 48 participants 25 participants
77.1 72.0
Day 13 Number Analyzed 46 participants 26 participants
76.1 69.2
Day 14 Number Analyzed 48 participants 26 participants
77.1 65.4
Day 15 Number Analyzed 36 participants 19 participants
63.9 57.9
Day 16 Number Analyzed 35 participants 18 participants
71.4 66.7
Day 17 Number Analyzed 35 participants 19 participants
74.3 63.2
Day 18 Number Analyzed 30 participants 19 participants
70.0 57.9
Day 19 Number Analyzed 31 participants 17 participants
77.4 58.8
Day 20 Number Analyzed 33 participants 19 participants
81.8 63.2
Day 21 Number Analyzed 34 participants 20 participants
79.4 60.0
Day 22 Number Analyzed 29 participants 18 participants
86.2 61.1
Day 23 Number Analyzed 32 participants 17 participants
78.1 70.6
Day 24 Number Analyzed 29 participants 15 participants
86.2 66.7
Day 25 Number Analyzed 26 participants 13 participants
92.3 69.2
Day 26 Number Analyzed 27 participants 14 participants
81.5 57.1
Day 27 Number Analyzed 24 participants 10 participants
83.3 50.0
Day 28 Number Analyzed 18 participants 9 participants
77.8 44.4
Day 29 Number Analyzed 5 participants 3 participants
80.0 66.7
Day 30 Number Analyzed 3 participants 1 participants
100.0 0
Day 31 Number Analyzed 1 participants 0 participants
100.0
Day 32 Number Analyzed 2 participants 0 participants
100.0
Day 33 Number Analyzed 1 participants 0 participants
100
Time Frame Up to 28 days
Adverse Event Reporting Description Safety analysis set included all participants who received at least one dose of study drug(s) and were analyzed by drug received.
 
Arm/Group Title Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Hide Arm/Group Description Participants received pimodivir 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the estimated-glomerular filtration rate (eGFR) value. Participants received matching placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. Dose of oseltamivir was adjusted from 75 mg to 30 mg and vice versa during the course of treatment based on the eGFR value.
All-Cause Mortality
Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/64 (1.56%)   0/35 (0.00%) 
Hide Serious Adverse Events
Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   11/64 (17.19%)   4/35 (11.43%) 
Blood and lymphatic system disorders     
Neutropenia * 1  0/64 (0.00%)  1/35 (2.86%) 
Cardiac disorders     
Cardiac arrest * 1  1/64 (1.56%)  0/35 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  1/64 (1.56%)  0/35 (0.00%) 
Infections and infestations     
Bacterial infection * 1  1/64 (1.56%)  0/35 (0.00%) 
Infective pulmonary exacerbation of cystic fibrosis * 1  0/64 (0.00%)  1/35 (2.86%) 
Oral candidiasis * 1  1/64 (1.56%)  0/35 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung neoplasm malignant * 1  1/64 (1.56%)  0/35 (0.00%) 
Nervous system disorders     
Cerebrovascular accident * 1  0/64 (0.00%)  1/35 (2.86%) 
Renal and urinary disorders     
Bladder outlet obstruction * 1  0/64 (0.00%)  1/35 (2.86%) 
Renal failure * 1  1/64 (1.56%)  0/35 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Bronchial hyperreactivity * 1  1/64 (1.56%)  0/35 (0.00%) 
Chronic obstructive pulmonary disease * 1  1/64 (1.56%)  0/35 (0.00%) 
Pulmonary oedema * 1  1/64 (1.56%)  0/35 (0.00%) 
Respiratory failure * 1  1/64 (1.56%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis exfoliative * 1  1/64 (1.56%)  0/35 (0.00%) 
Vascular disorders     
Aortic dissection * 1  1/64 (1.56%)  0/35 (0.00%) 
Circulatory collapse * 1  1/64 (1.56%)  0/35 (0.00%) 
Hypotension * 1  1/64 (1.56%)  0/35 (0.00%) 
Orthostatic hypotension * 1  1/64 (1.56%)  0/35 (0.00%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pimodivir 600 mg Plus Oseltamivir 75 mg Placebo Plus Oseltamivir 75 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   45/64 (70.31%)   24/35 (68.57%) 
Blood and lymphatic system disorders     
Neutropenia * 1  1/64 (1.56%)  0/35 (0.00%) 
Polycythaemia * 1  0/64 (0.00%)  1/35 (2.86%) 
Splenomegaly * 1  1/64 (1.56%)  0/35 (0.00%) 
Thrombocytosis * 1  0/64 (0.00%)  1/35 (2.86%) 
Cardiac disorders     
Atrioventricular block first degree * 1  1/64 (1.56%)  0/35 (0.00%) 
Sinus bradycardia * 1  1/64 (1.56%)  0/35 (0.00%) 
Ear and labyrinth disorders     
Ear pain * 1  1/64 (1.56%)  0/35 (0.00%) 
Vertigo * 1  1/64 (1.56%)  1/35 (2.86%) 
Eye disorders     
Amaurosis * 1  1/64 (1.56%)  0/35 (0.00%) 
Eye pruritus * 1  1/64 (1.56%)  0/35 (0.00%) 
Eyelid oedema * 1  1/64 (1.56%)  0/35 (0.00%) 
Lacrimation increased * 1  0/64 (0.00%)  1/35 (2.86%) 
Photopsia * 1  0/64 (0.00%)  1/35 (2.86%) 
Gastrointestinal disorders     
Abdominal discomfort * 1  0/64 (0.00%)  2/35 (5.71%) 
Abdominal pain * 1  1/64 (1.56%)  0/35 (0.00%) 
Abdominal pain upper * 1  1/64 (1.56%)  0/35 (0.00%) 
Cheilitis * 1  1/64 (1.56%)  0/35 (0.00%) 
Constipation * 1  2/64 (3.13%)  0/35 (0.00%) 
Diarrhoea * 1  13/64 (20.31%)  4/35 (11.43%) 
Dry mouth * 1  1/64 (1.56%)  0/35 (0.00%) 
Dyspepsia * 1  4/64 (6.25%)  1/35 (2.86%) 
Gastrointestinal haemorrhage * 1  1/64 (1.56%)  0/35 (0.00%) 
Gastrooesophageal reflux disease * 1  1/64 (1.56%)  0/35 (0.00%) 
Gingival pain * 1  1/64 (1.56%)  0/35 (0.00%) 
Nausea * 1  9/64 (14.06%)  5/35 (14.29%) 
Oral pain * 1  2/64 (3.13%)  0/35 (0.00%) 
Vomiting * 1  6/64 (9.38%)  2/35 (5.71%) 
General disorders     
Asthenia * 1  0/64 (0.00%)  1/35 (2.86%) 
Chest pain * 1  1/64 (1.56%)  0/35 (0.00%) 
Chills * 1  1/64 (1.56%)  0/35 (0.00%) 
Face oedema * 1  1/64 (1.56%)  0/35 (0.00%) 
Fatigue * 1  4/64 (6.25%)  1/35 (2.86%) 
Malaise * 1  1/64 (1.56%)  0/35 (0.00%) 
Oedema peripheral * 1  2/64 (3.13%)  0/35 (0.00%) 
Pyrexia * 1  4/64 (6.25%)  0/35 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis * 1  1/64 (1.56%)  0/35 (0.00%) 
Hepatic steatosis * 1  1/64 (1.56%)  0/35 (0.00%) 
Hyperbilirubinaemia * 1  1/64 (1.56%)  0/35 (0.00%) 
Hypertransaminasaemia * 1  1/64 (1.56%)  0/35 (0.00%) 
Infections and infestations     
Hepatitis C * 1  0/64 (0.00%)  1/35 (2.86%) 
Oral candidiasis * 1  1/64 (1.56%)  0/35 (0.00%) 
Oral herpes * 1  1/64 (1.56%)  0/35 (0.00%) 
Pulmonary tuberculosis * 1  1/64 (1.56%)  0/35 (0.00%) 
Respiratory tract infection * 1  0/64 (0.00%)  1/35 (2.86%) 
Rhinitis * 1  1/64 (1.56%)  0/35 (0.00%) 
Sinusitis * 1  2/64 (3.13%)  0/35 (0.00%) 
Urinary tract infection * 1  2/64 (3.13%)  0/35 (0.00%) 
Injury, poisoning and procedural complications     
Fall * 1  0/64 (0.00%)  1/35 (2.86%) 
Post-traumatic pain * 1  1/64 (1.56%)  0/35 (0.00%) 
Procedural pneumothorax * 1  1/64 (1.56%)  0/35 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  1/64 (1.56%)  0/35 (0.00%) 
Aspartate aminotransferase increased * 1  1/64 (1.56%)  0/35 (0.00%) 
Blood bicarbonate decreased * 1  1/64 (1.56%)  0/35 (0.00%) 
Blood creatinine increased * 1  0/64 (0.00%)  2/35 (5.71%) 
Blood lactate dehydrogenase increased * 1  1/64 (1.56%)  0/35 (0.00%) 
Blood triglycerides increased * 1  1/64 (1.56%)  0/35 (0.00%) 
Glomerular filtration rate decreased * 1  0/64 (0.00%)  1/35 (2.86%) 
Hepatic enzyme increased * 1  0/64 (0.00%)  1/35 (2.86%) 
International normalised ratio * 1  0/64 (0.00%)  1/35 (2.86%) 
Liver function test increased * 1  0/64 (0.00%)  1/35 (2.86%) 
Lymphocyte count decreased * 1  1/64 (1.56%)  0/35 (0.00%) 
Neutrophil count increased * 1  1/64 (1.56%)  0/35 (0.00%) 
Transaminases increased * 1  1/64 (1.56%)  0/35 (0.00%) 
Troponin increased * 1  0/64 (0.00%)  1/35 (2.86%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  2/64 (3.13%)  1/35 (2.86%) 
Gout * 1  0/64 (0.00%)  1/35 (2.86%) 
Hyperglycaemia * 1  0/64 (0.00%)  1/35 (2.86%) 
Hypertriglyceridaemia * 1  1/64 (1.56%)  0/35 (0.00%) 
Hypokalaemia * 1  2/64 (3.13%)  1/35 (2.86%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  0/64 (0.00%)  2/35 (5.71%) 
Arthritis * 1  0/64 (0.00%)  1/35 (2.86%) 
Back pain * 1  2/64 (3.13%)  1/35 (2.86%) 
Muscle spasms * 1  1/64 (1.56%)  0/35 (0.00%) 
Musculoskeletal chest pain * 1  1/64 (1.56%)  1/35 (2.86%) 
Musculoskeletal pain * 1  0/64 (0.00%)  1/35 (2.86%) 
Myalgia * 1  2/64 (3.13%)  0/35 (0.00%) 
Neck pain * 1  2/64 (3.13%)  1/35 (2.86%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 1  1/64 (1.56%)  0/35 (0.00%) 
Nervous system disorders     
Dizziness * 1  2/64 (3.13%)  0/35 (0.00%) 
Dizziness postural * 1  1/64 (1.56%)  0/35 (0.00%) 
Dysgeusia * 1  1/64 (1.56%)  0/35 (0.00%) 
Headache * 1  7/64 (10.94%)  3/35 (8.57%) 
Paraesthesia * 1  1/64 (1.56%)  0/35 (0.00%) 
Presyncope * 1  1/64 (1.56%)  0/35 (0.00%) 
Restless legs syndrome * 1  1/64 (1.56%)  0/35 (0.00%) 
Somnolence * 1  1/64 (1.56%)  0/35 (0.00%) 
Syncope * 1  1/64 (1.56%)  1/35 (2.86%) 
Psychiatric disorders     
Confusional state * 1  1/64 (1.56%)  0/35 (0.00%) 
Hallucination * 1  1/64 (1.56%)  0/35 (0.00%) 
Insomnia * 1  3/64 (4.69%)  0/35 (0.00%) 
Renal and urinary disorders     
Dysuria * 1  0/64 (0.00%)  1/35 (2.86%) 
Nocturia * 1  1/64 (1.56%)  0/35 (0.00%) 
Proteinuria * 1  1/64 (1.56%)  0/35 (0.00%) 
Urinary hesitation * 1  1/64 (1.56%)  0/35 (0.00%) 
Reproductive system and breast disorders     
Prostatomegaly * 1  0/64 (0.00%)  1/35 (2.86%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/64 (1.56%)  1/35 (2.86%) 
Bronchospasm * 1  1/64 (1.56%)  0/35 (0.00%) 
Cough * 1  4/64 (6.25%)  4/35 (11.43%) 
Dyspnoea * 1  2/64 (3.13%)  0/35 (0.00%) 
Epistaxis * 1  2/64 (3.13%)  0/35 (0.00%) 
Haemothorax * 1  0/64 (0.00%)  1/35 (2.86%) 
Increased upper airway secretion * 1  1/64 (1.56%)  0/35 (0.00%) 
Oropharyngeal discomfort * 1  1/64 (1.56%)  0/35 (0.00%) 
Oropharyngeal pain * 1  1/64 (1.56%)  1/35 (2.86%) 
Rhinorrhoea * 1  1/64 (1.56%)  1/35 (2.86%) 
Sneezing * 1  1/64 (1.56%)  0/35 (0.00%) 
Wheezing * 1  1/64 (1.56%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders     
Blister * 1  1/64 (1.56%)  0/35 (0.00%) 
Dyshidrotic eczema * 1  1/64 (1.56%)  0/35 (0.00%) 
Hyperhidrosis * 1  1/64 (1.56%)  0/35 (0.00%) 
Prurigo * 1  1/64 (1.56%)  0/35 (0.00%) 
Pruritus * 1  1/64 (1.56%)  0/35 (0.00%) 
Rash * 1  1/64 (1.56%)  1/35 (2.86%) 
Rash maculo-papular * 1  1/64 (1.56%)  0/35 (0.00%) 
Skin lesion * 1  0/64 (0.00%)  1/35 (2.86%) 
Vascular disorders     
Hypertension * 1  1/64 (1.56%)  0/35 (0.00%) 
Phlebitis * 1  1/64 (1.56%)  0/35 (0.00%) 
1
Term from vocabulary, MedDRA Version 19.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02532283    
Other Study ID Numbers: CR107746
2015-003002-17 ( EudraCT Number )
63623872FLZ2002 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: August 21, 2015
First Posted: August 25, 2015
Results First Submitted: February 6, 2020
Results First Posted: March 27, 2020
Last Update Posted: March 27, 2020