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
Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT02532283
Collaborator
(none)
102
68
2
15.1
1.5
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the Pharmacokinetic parameters of JNJ-63623872 in combination with oseltamivir in elderly participants (aged 65 to <= 85 years) compared to adults (aged 18 to <= 64 years) with influenza A infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the effect of JNJ-63623872 in combination with oseltamivir in participants with influenza A infection. The study consists of 3 Phases: Screening visit (1 Day), participants who meet all eligibility criteria will be randomized in a 2:1 ratio to receive study drug in double-blind treatment Phase (7 Days) and follow up Phase (21 Days). The duration of participation in the study for each participant is approximately 28 Days. Primarily Pharmacokinetic parameters of JNJ-63623872 will be measured. Participants' safety will be monitored throughout the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Patients With Influenza A Infection
Actual Study Start Date
:
Dec 11, 2015
Actual Primary Completion Date
:
Feb 24, 2017
Actual Study Completion Date
:
Mar 15, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JNJ-63623872 plus Oseltamivir Participants will be administered JNJ-63623872 600 milligram (mg) tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. |
Drug: JNJ-63623872
Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.
Drug: Oseltamivir
Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
|
| Experimental: Placebo plus Oseltamivir Participants will be administered placebo tablets and oseltamivir 75 mg capsules orally twice daily for 7 days. |
Drug: Placebo
Participants will be administered placebo tablets orally twice daily for 7 days.
Drug: Oseltamivir
Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of Pimodivir [Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3]
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).
- Minimum Observed Plasma Concentration (Cmin) of Pimodivir [Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3]
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).
- Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir [Pre-dose, 1, 2, 4, 6, 8, 10 and 12 hours post-dose on Day 3]
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).
Secondary Outcome Measures
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs) [Up to 28 Days]
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 to Influenza A Viral Negativity [Up to 14 Days]
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.
- Influenza Viral Load Over Time [Baseline, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 and 14]
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.
- Rate of Decline in Viral Load [Up to Day 7]
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.
- Area Under the Plasma Concentration-time Curve (AUC) of Viral Load [Baseline up to Day 8]
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.
- Percentage of Participants With Influenza Complications [Up to 28 Days]
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.
- Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score [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]
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 to Improvement of Vital Signs [Up to 28 Days]
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 to Improvement of Respiratory Status [Up to 28 Days]
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).
- Percentage of Participants With Clinical Outcome Based on Ordinal Scale [Day 8]
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.
- Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir [Up to 28 Days]
Number of participants with emergence (from baseline) of drug resistance mutations detected by genotype or phenotype were reported.
- Time to Return to Premorbid Functional Status [Up to Day 33]
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 to Hospital Discharge [Up to 28 Days]
Time to hospital discharge was calculated from the date of first study drug intake during hospitalization up to date of discharge.
- Time to Return to Usual Health [Up to Day 33]
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 to Significant Reduction in FLU-PRO Influenza Symptom Severity [Up to Day 33]
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).
- Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) [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]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection
-
Participant tested positive for influenza A infection within 1 day of signing of the informed consent form (ICF)/assent form using a polymerase chain reaction (PCR)-based rapid molecular diagnostic assay
-
Participants must be capable of swallowing study medication tablets and capsules
-
Each participant (or their legally acceptable representative) must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
-
Participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol
Exclusion Criteria:
-
Participant received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to Screening
-
Participant is unwilling to undergo regular nasal Mid-turbinate (MT) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens
-
Participant is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant)
-
Participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration
-
Participant has an estimated glomerular filtration rate (eGFR) less than or equal to (<=)30 milliliter (mL)/minute (min)/1.73 meter2 (m2) according to the Modification of Diet in Renal Disease (MDRD) equation, assessed at Screening or based on the most recent clinically relevant creatinine value if available
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fresno | California | United States | ||
| 2 | Long Beach | California | United States | ||
| 3 | Stanford | California | United States | ||
| 4 | Atlantis | Florida | United States | ||
| 5 | Miami | Florida | United States | ||
| 6 | Chicago | Illinois | United States | ||
| 7 | Detroit | Michigan | United States | ||
| 8 | Royal Oak | Michigan | United States | ||
| 9 | Troy | Michigan | United States | ||
| 10 | Minneapolis | Minnesota | United States | ||
| 11 | Saint Louis | Missouri | United States | ||
| 12 | Teaneck | New Jersey | United States | ||
| 13 | Winston-Salem | North Carolina | United States | ||
| 14 | Houston | Texas | United States | ||
| 15 | Cairns | Australia | |||
| 16 | South Brisbane | Australia | |||
| 17 | Westmead | Australia | |||
| 18 | Aalst | Belgium | |||
| 19 | Bruxelles | Belgium | |||
| 20 | Leuven | Belgium | |||
| 21 | Passo Fundo | Brazil | |||
| 22 | Porto Alegre | Brazil | |||
| 23 | Sao Paulo | Brazil | |||
| 24 | Hamilton | Ontario | Canada | ||
| 25 | Québec | Quebec | Canada | ||
| 26 | Dijon | France | |||
| 27 | Grenoble | France | |||
| 28 | Limoges | France | |||
| 29 | Lyon | France | |||
| 30 | Nantes | France | |||
| 31 | Paris | France | |||
| 32 | Poitiers | France | |||
| 33 | Rennes | France | |||
| 34 | Saint-Priest en Jarez | France | |||
| 35 | Tours Cedex 9 | France | |||
| 36 | Donaustauf | Germany | |||
| 37 | Jena | Germany | |||
| 38 | Hong Kong | Hong Kong | |||
| 39 | Kota Bharu | Malaysia | |||
| 40 | Kuala Lumpur | Malaysia | |||
| 41 | Kuala | Malaysia | |||
| 42 | Kuching | Malaysia | |||
| 43 | Melaka | Malaysia | |||
| 44 | Miri | Malaysia | |||
| 45 | Sungai Buloh | Malaysia | |||
| 46 | Taiping | Malaysia | |||
| 47 | Rotterdam | Netherlands | |||
| 48 | Utrecht | Netherlands | |||
| 49 | Zutphen | Netherlands | |||
| 50 | Hamilton | New Zealand | |||
| 51 | Singapore | Singapore | |||
| 52 | Alicante | Spain | |||
| 53 | Barcelona | Spain | |||
| 54 | Bizkaia | Spain | |||
| 55 | Elche | Spain | |||
| 56 | Granada | Spain | |||
| 57 | Madrid | Spain | |||
| 58 | Mataró | Spain | |||
| 59 | San Sebastián | Spain | |||
| 60 | Vigo | Spain | |||
| 61 | Malmö | Sweden | |||
| 62 | Umeå | Sweden | |||
| 63 | Uppsala | Sweden | |||
| 64 | Ankara | Turkey | |||
| 65 | Eskişehir | Turkey | |||
| 66 | Istanbul | Turkey | |||
| 67 | Izmir | Turkey | |||
| 68 | Trabzon | Turkey |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02532283
Other Study ID Numbers:
- CR107746
- 2015-003002-17
- 63623872FLZ2002
First Posted:
Aug 25, 2015
Last Update Posted:
Mar 27, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Janssen Research & Development, LLC
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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 |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Pimodivir 600 mg Plus Oseltamivir 75 mg | Placebo Plus Oseltamivir 75 mg | Total |
|---|---|---|---|
| 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 Participants | 64 | 35 | 99 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
58.1
(16.06)
|
57.2
(13.71)
|
57.8
(15.21)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
27
42.2%
|
18
51.4%
|
45
45.5%
|
| Male |
37
57.8%
|
17
48.6%
|
54
54.5%
|
| Ethnicity (NIH/OMB) (Count of 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%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| American Indian or Alaska Native |
1
1.6%
|
0
0%
|
1
1%
|
| Asian |
5
7.8%
|
7
20%
|
12
12.1%
|
| Black or African American |
6
9.4%
|
7
20%
|
13
13.1%
|
| More than one race |
0
0%
|
1
2.9%
|
1
1%
|
| Other |
2
3.1%
|
1
2.9%
|
3
3%
|
| Unknown or Not Reported |
2
3.1%
|
0
0%
|
2
2%
|
| White |
48
75%
|
19
54.3%
|
67
67.7%
|
| Region of Enrollment (Count of Participants) | |||
| BELGIUM |
3
4.7%
|
0
0%
|
3
3%
|
| FRANCE |
6
9.4%
|
2
5.7%
|
8
8.1%
|
| GERMANY |
0
0%
|
2
5.7%
|
2
2%
|
| HONG KONG |
0
0%
|
1
2.9%
|
1
1%
|
| MALAYSIA |
3
4.7%
|
4
11.4%
|
7
7.1%
|
| NETHERLANDS |
3
4.7%
|
1
2.9%
|
4
4%
|
| SINGAPORE |
1
1.6%
|
0
0%
|
1
1%
|
| SPAIN |
16
25%
|
7
20%
|
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%
|
Outcome Measures
| Title | Maximum Observed Plasma Concentration (Cmax) of Pimodivir |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 15 | 20 |
| Mean (Standard Deviation) [Nanogram per milliliter (ng/mL)] |
5933
(4427)
|
5378
(3888)
|
| Title | Minimum Observed Plasma Concentration (Cmin) of Pimodivir |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 15 | 21 |
| Mean (Standard Deviation) [ng/mL] |
738
(892)
|
507
(414)
|
| Title | Area Under the Plasma Concentration-time Curve From Time of Administration to 12 Hours After Dosing (AUC [0-12]) of Pimodivir |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 15 | 20 |
| Mean (Standard Deviation) [nanogram hours per milliliter (ng*h/mL)] |
27386
(25191)
|
20101
(11063)
|
| Title | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious AEs (TESAEs) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 64 | 35 |
| TEAEs |
48
75%
|
25
71.4%
|
| TESAEs |
11
17.2%
|
4
11.4%
|
| Title | Time to Influenza A Viral Negativity |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 63 | 32 |
| Median (95% Confidence Interval) [Days] |
9.53
|
9.74
|
| Title | Influenza Viral Load Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 58 | 30 |
| Baseline |
5.45
(1.737)
|
5.90
(1.513)
|
| Day 1 |
6.40
(0.757)
|
4.43
(NA)
|
| Day 2 |
4.75
(1.290)
|
4.63
(1.757)
|
| Day 3 |
3.83
(1.310)
|
3.98
(1.924)
|
| Day 4 |
3.00
(1.486)
|
3.14
(1.806)
|
| Day 5 |
2.57
(1.716)
|
2.60
(1.803)
|
| Day 6 |
2.07
(1.454)
|
2.18
(2.457)
|
| Day 7 |
1.95
(1.478)
|
2.38
(2.212)
|
| Day 8 |
1.82
(1.709)
|
1.43
(1.648)
|
| Day 9 |
1.51
(1.034)
|
0.00
(NA)
|
| Day 10 |
1.39
(1.676)
|
0.99
(1.295)
|
| Day 11 |
0.42
(1.017)
|
0.00
(NA)
|
| Day 12 |
1.06
(1.499)
|
|
| Day 13 |
1.06
(1.499)
|
|
| Day 14 |
1.05
(1.636)
|
0.20
(0.646)
|
| Title | Rate of Decline in Viral Load |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 63 | 32 |
| Median (95% Confidence Interval) [Log10 vp/mL/day] |
-0.35
|
-0.42
|
| Title | Area Under the Plasma Concentration-time Curve (AUC) of Viral Load |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 63 | 32 |
| Mean (95% Confidence Interval) [Days*vp/mL] |
22.8
|
22.1
|
| Title | Percentage of Participants With Influenza Complications |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 63 | 32 |
| All complications |
7.9
12.3%
|
15.6
44.6%
|
| Bacterial pneumonia |
0
0%
|
0
0%
|
| Bacterial superinfections |
1.6
2.5%
|
3.1
8.9%
|
| Respiratory failure |
1.6
2.5%
|
0
0%
|
| Pulmonary disease |
3.2
5%
|
6.3
18%
|
| Cardiovascular and Cerebrovascular disease |
1.6
2.5%
|
0
0%
|
| Title | Change From Baseline in Influenza Patient-Reported Outcome Questionnaire (FLU-PRO) Total Score |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 38 | 32 |
| Day 1 |
-0.08
(0.247)
|
-0.11
(0.349)
|
| Day 2 |
-0.48
(0.644)
|
-0.33
(0.798)
|
| Day 3 |
-0.60
(0.624)
|
-0.52
(0.641)
|
| Day 4 |
-0.71
(0.702)
|
-0.56
(0.625)
|
| Day 5 |
-0.76
(0.689)
|
-0.67
(0.643)
|
| Day 6 |
-0.85
(0.692)
|
-0.75
(0.659)
|
| Day 7 |
-0.87
(0.738)
|
-0.69
(0.623)
|
| Day 8 |
-0.89
(0.729)
|
-0.80
(0.764)
|
| Day 9 |
-0.93
(0.764)
|
-0.84
(0.732)
|
| Day 10 |
-0.91
(0.723)
|
-0.81
(0.743)
|
| Day 11 |
-0.87
(0.756)
|
-0.76
(0.534)
|
| Day 12 |
-0.87
(0.725)
|
-0.89
(0.695)
|
| Day 13 |
-0.93
(0.702)
|
-0.94
(0.650)
|
| Day 14 |
-0.85
(0.613)
|
-0.92
(0.670)
|
| Day 15 |
-0.88
(0.630)
|
-0.90
(0.724)
|
| Day 16 |
-0.84
(0.588)
|
-0.90
(0.762)
|
| Day 17 |
-0.98
(0.690)
|
-0.97
(0.774)
|
| Day 18 |
-1.06
(0.753)
|
-1.00
(0.868)
|
| Day 19 |
-1.06
(0.749)
|
-1.05
(0.880)
|
| Day 20 |
-1.03
(0.710)
|
-1.03
(0.847)
|
| Day 21 |
-1.00
(0.701)
|
-0.98
(0.849)
|
| Day 22 |
-1.02
(0.789)
|
-0.92
(0.690)
|
| Day 23 |
-1.11
(0.858)
|
-0.96
(0.731)
|
| Day 24 |
-0.87
(0.534)
|
-0.91
(0.580)
|
| Day 25 |
-0.94
(0.659)
|
-0.85
(0.661)
|
| Day 26 |
-0.86
(0.755)
|
-0.87
(0.742)
|
| Day 27 |
-1.02
(0.745)
|
-0.74
(0.734)
|
| Day 28 |
-0.60
(0.505)
|
-0.82
(0.675)
|
| Day 29 |
-1.13
(0.354)
|
-1.63
(0.398)
|
| Day 30 |
-0.61
(0.552)
|
|
| Day 31 |
-0.75
(NA)
|
|
| Day 32 |
-0.61
(0.420)
|
|
| Day 33 |
-0.94
(NA)
|
| Title | Time to Improvement of Vital Signs |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 60 | 28 |
| Median (95% Confidence Interval) [Hours] |
169.92
|
69.90
|
| Title | Time to Improvement of Respiratory Status |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 60 | 28 |
| Median (95% Confidence Interval) [Hours] |
33.53
|
40.57
|
| Title | Percentage of Participants With Clinical Outcome Based on Ordinal Scale |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 62 | 31 |
| Day 8: NH and Continues Activities |
40.3
63%
|
29.0
82.9%
|
| Day 8: NH, but Unable to Continue Activity |
27.4
42.8%
|
45.2
129.1%
|
| Day 8: Non-ICU+No Supplemental Oxygen |
14.5
22.7%
|
6.5
18.6%
|
| Day 8: Non-ICU+Supplemental Oxygen |
8.1
12.7%
|
3.2
9.1%
|
| Day 8: Death |
1.6
2.5%
|
0
0%
|
| Day 8: Missing |
8.1
12.7%
|
16.1
46%
|
| Title | Number of Participants With the Emergence of Drug Resistance Mutations With Oseltamivir (OST) and Pimodivir |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 63 | 32 |
| Emergence of Pimodivir Mutation |
0
0%
|
0
0%
|
| Emergence of OST Mutation |
0
0%
|
1
2.9%
|
| Title | Time to Return to Premorbid Functional Status |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 60 | 32 |
| Median (95% Confidence Interval) [Hours] |
142.85
|
154.83
|
| Title | Time to Hospital Discharge |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 63 | 32 |
| Median (95% Confidence Interval) [Days] |
4.00
|
4.00
|
| Title | Time to Return to Usual Health |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 60 | 32 |
| Median (95% Confidence Interval) [Hours] |
217.05
|
338.83
|
| Title | Time to Significant Reduction in FLU-PRO Influenza Symptom Severity |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 60 | 32 |
| Median (95% Confidence Interval) [Hours] |
118.45
|
218.72
|
| Title | Percentage of Participants With Significant Reduction in FLU-PRO All Influenza Symptoms (Mild or None for All Symptoms) |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| 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. |
| Measure Participants | 55 | 30 |
| Day 1 |
9.4
14.7%
|
18.2
52%
|
| Day 2 |
37.3
58.3%
|
34.6
98.9%
|
| Day 3 |
36.4
56.9%
|
26.7
76.3%
|
| Day 4 |
42.0
65.6%
|
38.5
110%
|
| Day 5 |
54.0
84.4%
|
37.5
107.1%
|
| Day 6 |
59.2
92.5%
|
40.0
114.3%
|
| Day 7 |
55.1
86.1%
|
34.8
99.4%
|
| Day 8 |
62.7
98%
|
32.0
91.4%
|
| Day 9 |
76.0
118.8%
|
38.5
110%
|
| Day 10 |
76.5
119.5%
|
53.8
153.7%
|
| Day 11 |
70.2
109.7%
|
59.1
168.9%
|
| Day 12 |
77.1
120.5%
|
72.0
205.7%
|
| Day 13 |
76.1
118.9%
|
69.2
197.7%
|
| Day 14 |
77.1
120.5%
|
65.4
186.9%
|
| Day 15 |
63.9
99.8%
|
57.9
165.4%
|
| Day 16 |
71.4
111.6%
|
66.7
190.6%
|
| Day 17 |
74.3
116.1%
|
63.2
180.6%
|
| Day 18 |
70.0
109.4%
|
57.9
165.4%
|
| Day 19 |
77.4
120.9%
|
58.8
168%
|
| Day 20 |
81.8
127.8%
|
63.2
180.6%
|
| Day 21 |
79.4
124.1%
|
60.0
171.4%
|
| Day 22 |
86.2
134.7%
|
61.1
174.6%
|
| Day 23 |
78.1
122%
|
70.6
201.7%
|
| Day 24 |
86.2
134.7%
|
66.7
190.6%
|
| Day 25 |
92.3
144.2%
|
69.2
197.7%
|
| Day 26 |
81.5
127.3%
|
57.1
163.1%
|
| Day 27 |
83.3
130.2%
|
50.0
142.9%
|
| Day 28 |
77.8
121.6%
|
44.4
126.9%
|
| Day 29 |
80.0
125%
|
66.7
190.6%
|
| Day 30 |
100.0
156.3%
|
0
0%
|
| Day 31 |
100.0
156.3%
|
|
| Day 32 |
100.0
156.3%
|
|
| Day 33 |
100
156.3%
|
Adverse Events
| 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 | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/64 (1.6%) | 0/35 (0%) | ||
Serious Adverse Events |
||||
| Pimodivir 600 mg Plus Oseltamivir 75 mg | Placebo Plus Oseltamivir 75 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/64 (17.2%) | 4/35 (11.4%) | ||
| Blood and lymphatic system disorders | ||||
| Neutropenia | 0/64 (0%) | 1/35 (2.9%) | ||
| Cardiac disorders | ||||
| Cardiac arrest | 1/64 (1.6%) | 0/35 (0%) | ||
| Immune system disorders | ||||
| Hypersensitivity | 1/64 (1.6%) | 0/35 (0%) | ||
| Infections and infestations | ||||
| Bacterial infection | 1/64 (1.6%) | 0/35 (0%) | ||
| Infective pulmonary exacerbation of cystic fibrosis | 0/64 (0%) | 1/35 (2.9%) | ||
| Oral candidiasis | 1/64 (1.6%) | 0/35 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Lung neoplasm malignant | 1/64 (1.6%) | 0/35 (0%) | ||
| Nervous system disorders | ||||
| Cerebrovascular accident | 0/64 (0%) | 1/35 (2.9%) | ||
| Renal and urinary disorders | ||||
| Bladder outlet obstruction | 0/64 (0%) | 1/35 (2.9%) | ||
| Renal failure | 1/64 (1.6%) | 0/35 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchial hyperreactivity | 1/64 (1.6%) | 0/35 (0%) | ||
| Chronic obstructive pulmonary disease | 1/64 (1.6%) | 0/35 (0%) | ||
| Pulmonary oedema | 1/64 (1.6%) | 0/35 (0%) | ||
| Respiratory failure | 1/64 (1.6%) | 0/35 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis exfoliative | 1/64 (1.6%) | 0/35 (0%) | ||
| Vascular disorders | ||||
| Aortic dissection | 1/64 (1.6%) | 0/35 (0%) | ||
| Circulatory collapse | 1/64 (1.6%) | 0/35 (0%) | ||
| Hypotension | 1/64 (1.6%) | 0/35 (0%) | ||
| Orthostatic hypotension | 1/64 (1.6%) | 0/35 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Pimodivir 600 mg Plus Oseltamivir 75 mg | Placebo Plus Oseltamivir 75 mg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 45/64 (70.3%) | 24/35 (68.6%) | ||
| Blood and lymphatic system disorders | ||||
| Neutropenia | 1/64 (1.6%) | 0/35 (0%) | ||
| Polycythaemia | 0/64 (0%) | 1/35 (2.9%) | ||
| Splenomegaly | 1/64 (1.6%) | 0/35 (0%) | ||
| Thrombocytosis | 0/64 (0%) | 1/35 (2.9%) | ||
| Cardiac disorders | ||||
| Atrioventricular block first degree | 1/64 (1.6%) | 0/35 (0%) | ||
| Sinus bradycardia | 1/64 (1.6%) | 0/35 (0%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 1/64 (1.6%) | 0/35 (0%) | ||
| Vertigo | 1/64 (1.6%) | 1/35 (2.9%) | ||
| Eye disorders | ||||
| Amaurosis | 1/64 (1.6%) | 0/35 (0%) | ||
| Eye pruritus | 1/64 (1.6%) | 0/35 (0%) | ||
| Eyelid oedema | 1/64 (1.6%) | 0/35 (0%) | ||
| Lacrimation increased | 0/64 (0%) | 1/35 (2.9%) | ||
| Photopsia | 0/64 (0%) | 1/35 (2.9%) | ||
| Gastrointestinal disorders | ||||
| Abdominal discomfort | 0/64 (0%) | 2/35 (5.7%) | ||
| Abdominal pain | 1/64 (1.6%) | 0/35 (0%) | ||
| Abdominal pain upper | 1/64 (1.6%) | 0/35 (0%) | ||
| Cheilitis | 1/64 (1.6%) | 0/35 (0%) | ||
| Constipation | 2/64 (3.1%) | 0/35 (0%) | ||
| Diarrhoea | 13/64 (20.3%) | 4/35 (11.4%) | ||
| Dry mouth | 1/64 (1.6%) | 0/35 (0%) | ||
| Dyspepsia | 4/64 (6.3%) | 1/35 (2.9%) | ||
| Gastrointestinal haemorrhage | 1/64 (1.6%) | 0/35 (0%) | ||
| Gastrooesophageal reflux disease | 1/64 (1.6%) | 0/35 (0%) | ||
| Gingival pain | 1/64 (1.6%) | 0/35 (0%) | ||
| Nausea | 9/64 (14.1%) | 5/35 (14.3%) | ||
| Oral pain | 2/64 (3.1%) | 0/35 (0%) | ||
| Vomiting | 6/64 (9.4%) | 2/35 (5.7%) | ||
| General disorders | ||||
| Asthenia | 0/64 (0%) | 1/35 (2.9%) | ||
| Chest pain | 1/64 (1.6%) | 0/35 (0%) | ||
| Chills | 1/64 (1.6%) | 0/35 (0%) | ||
| Face oedema | 1/64 (1.6%) | 0/35 (0%) | ||
| Fatigue | 4/64 (6.3%) | 1/35 (2.9%) | ||
| Malaise | 1/64 (1.6%) | 0/35 (0%) | ||
| Oedema peripheral | 2/64 (3.1%) | 0/35 (0%) | ||
| Pyrexia | 4/64 (6.3%) | 0/35 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholelithiasis | 1/64 (1.6%) | 0/35 (0%) | ||
| Hepatic steatosis | 1/64 (1.6%) | 0/35 (0%) | ||
| Hyperbilirubinaemia | 1/64 (1.6%) | 0/35 (0%) | ||
| Hypertransaminasaemia | 1/64 (1.6%) | 0/35 (0%) | ||
| Infections and infestations | ||||
| Hepatitis C | 0/64 (0%) | 1/35 (2.9%) | ||
| Oral candidiasis | 1/64 (1.6%) | 0/35 (0%) | ||
| Oral herpes | 1/64 (1.6%) | 0/35 (0%) | ||
| Pulmonary tuberculosis | 1/64 (1.6%) | 0/35 (0%) | ||
| Respiratory tract infection | 0/64 (0%) | 1/35 (2.9%) | ||
| Rhinitis | 1/64 (1.6%) | 0/35 (0%) | ||
| Sinusitis | 2/64 (3.1%) | 0/35 (0%) | ||
| Urinary tract infection | 2/64 (3.1%) | 0/35 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 0/64 (0%) | 1/35 (2.9%) | ||
| Post-traumatic pain | 1/64 (1.6%) | 0/35 (0%) | ||
| Procedural pneumothorax | 1/64 (1.6%) | 0/35 (0%) | ||
| Investigations | ||||
| Alanine aminotransferase increased | 1/64 (1.6%) | 0/35 (0%) | ||
| Aspartate aminotransferase increased | 1/64 (1.6%) | 0/35 (0%) | ||
| Blood bicarbonate decreased | 1/64 (1.6%) | 0/35 (0%) | ||
| Blood creatinine increased | 0/64 (0%) | 2/35 (5.7%) | ||
| Blood lactate dehydrogenase increased | 1/64 (1.6%) | 0/35 (0%) | ||
| Blood triglycerides increased | 1/64 (1.6%) | 0/35 (0%) | ||
| Glomerular filtration rate decreased | 0/64 (0%) | 1/35 (2.9%) | ||
| Hepatic enzyme increased | 0/64 (0%) | 1/35 (2.9%) | ||
| International normalised ratio | 0/64 (0%) | 1/35 (2.9%) | ||
| Liver function test increased | 0/64 (0%) | 1/35 (2.9%) | ||
| Lymphocyte count decreased | 1/64 (1.6%) | 0/35 (0%) | ||
| Neutrophil count increased | 1/64 (1.6%) | 0/35 (0%) | ||
| Transaminases increased | 1/64 (1.6%) | 0/35 (0%) | ||
| Troponin increased | 0/64 (0%) | 1/35 (2.9%) | ||
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 2/64 (3.1%) | 1/35 (2.9%) | ||
| Gout | 0/64 (0%) | 1/35 (2.9%) | ||
| Hyperglycaemia | 0/64 (0%) | 1/35 (2.9%) | ||
| Hypertriglyceridaemia | 1/64 (1.6%) | 0/35 (0%) | ||
| Hypokalaemia | 2/64 (3.1%) | 1/35 (2.9%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 0/64 (0%) | 2/35 (5.7%) | ||
| Arthritis | 0/64 (0%) | 1/35 (2.9%) | ||
| Back pain | 2/64 (3.1%) | 1/35 (2.9%) | ||
| Muscle spasms | 1/64 (1.6%) | 0/35 (0%) | ||
| Musculoskeletal chest pain | 1/64 (1.6%) | 1/35 (2.9%) | ||
| Musculoskeletal pain | 0/64 (0%) | 1/35 (2.9%) | ||
| Myalgia | 2/64 (3.1%) | 0/35 (0%) | ||
| Neck pain | 2/64 (3.1%) | 1/35 (2.9%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Basal cell carcinoma | 1/64 (1.6%) | 0/35 (0%) | ||
| Nervous system disorders | ||||
| Dizziness | 2/64 (3.1%) | 0/35 (0%) | ||
| Dizziness postural | 1/64 (1.6%) | 0/35 (0%) | ||
| Dysgeusia | 1/64 (1.6%) | 0/35 (0%) | ||
| Headache | 7/64 (10.9%) | 3/35 (8.6%) | ||
| Paraesthesia | 1/64 (1.6%) | 0/35 (0%) | ||
| Presyncope | 1/64 (1.6%) | 0/35 (0%) | ||
| Restless legs syndrome | 1/64 (1.6%) | 0/35 (0%) | ||
| Somnolence | 1/64 (1.6%) | 0/35 (0%) | ||
| Syncope | 1/64 (1.6%) | 1/35 (2.9%) | ||
| Psychiatric disorders | ||||
| Confusional state | 1/64 (1.6%) | 0/35 (0%) | ||
| Hallucination | 1/64 (1.6%) | 0/35 (0%) | ||
| Insomnia | 3/64 (4.7%) | 0/35 (0%) | ||
| Renal and urinary disorders | ||||
| Dysuria | 0/64 (0%) | 1/35 (2.9%) | ||
| Nocturia | 1/64 (1.6%) | 0/35 (0%) | ||
| Proteinuria | 1/64 (1.6%) | 0/35 (0%) | ||
| Urinary hesitation | 1/64 (1.6%) | 0/35 (0%) | ||
| Reproductive system and breast disorders | ||||
| Prostatomegaly | 0/64 (0%) | 1/35 (2.9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/64 (1.6%) | 1/35 (2.9%) | ||
| Bronchospasm | 1/64 (1.6%) | 0/35 (0%) | ||
| Cough | 4/64 (6.3%) | 4/35 (11.4%) | ||
| Dyspnoea | 2/64 (3.1%) | 0/35 (0%) | ||
| Epistaxis | 2/64 (3.1%) | 0/35 (0%) | ||
| Haemothorax | 0/64 (0%) | 1/35 (2.9%) | ||
| Increased upper airway secretion | 1/64 (1.6%) | 0/35 (0%) | ||
| Oropharyngeal discomfort | 1/64 (1.6%) | 0/35 (0%) | ||
| Oropharyngeal pain | 1/64 (1.6%) | 1/35 (2.9%) | ||
| Rhinorrhoea | 1/64 (1.6%) | 1/35 (2.9%) | ||
| Sneezing | 1/64 (1.6%) | 0/35 (0%) | ||
| Wheezing | 1/64 (1.6%) | 0/35 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Blister | 1/64 (1.6%) | 0/35 (0%) | ||
| Dyshidrotic eczema | 1/64 (1.6%) | 0/35 (0%) | ||
| Hyperhidrosis | 1/64 (1.6%) | 0/35 (0%) | ||
| Prurigo | 1/64 (1.6%) | 0/35 (0%) | ||
| Pruritus | 1/64 (1.6%) | 0/35 (0%) | ||
| Rash | 1/64 (1.6%) | 1/35 (2.9%) | ||
| Rash maculo-papular | 1/64 (1.6%) | 0/35 (0%) | ||
| Skin lesion | 0/64 (0%) | 1/35 (2.9%) | ||
| Vascular disorders | ||||
| Hypertension | 1/64 (1.6%) | 0/35 (0%) | ||
| Phlebitis | 1/64 (1.6%) | 0/35 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Senior Director |
|---|---|
| Organization | Janssen Research & Development, LLC |
| Phone | 844-434-4210 |
| ClinicalTrialDisclosure@its.jnj.com |
Responsible Party:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02532283
Other Study ID Numbers:
- CR107746
- 2015-003002-17
- 63623872FLZ2002
First Posted:
Aug 25, 2015
Last Update Posted:
Mar 27, 2020
Last Verified:
Mar 1, 2020