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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-194958 | Registry Identifier | JapicCTI |
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The purpose of the study is to investigate the pharmacokinetics (PK) of padesevonil in CYP2C19 genotyped healthy male Japanese study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extensive metabolizers | Experimental | Participants will receive assigned single and multiple doses of padsevonil. |
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| Intermediate metabolizers | Experimental | Participants will receive assigned single and multiple doses of padsevonil. |
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| Poor metabolizers | Experimental | Participants will receive assigned single and multiple doses of padsevonil. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Padsevonil | Drug | Padsevonil will be administered in predefined dosages. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil | Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points. | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
| Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil | AUC(0-t) is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
| Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil | AUC is the area under the plasma concentration-time curve from time zero to infinity. | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
| Terminal Half-life (t1/2) of a Single Dose Padsevonil | The t1/2 is the apparent terminal half-life. Geometric Means and Geometric Coefficient of Variations were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
| Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil | The tmax is the time to reach maximum plasma concentration. | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
| Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0083 001 | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38932723 | Derived | Chanteux H, MacPherson M, Kramer H, Otoul C, Okagaki T, Rospo C, De Bruyn S, Watling M, Bani M, Sciberras D. Overview of preclinical and clinical studies investigating pharmacokinetics and drug-drug interactions of padsevonil. Expert Opin Drug Metab Toxicol. 2024 Aug;20(8):841-855. doi: 10.1080/17425255.2024.2373108. Epub 2024 Jul 9. |
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Due to the small sample size in this trial, Individual Patient Data cannot be adequately anonymized and there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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Participant flow refers to the Safety Set.
The study started to enroll patients in September 2019 and concluded in December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Extensive Metabolizers | Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of padsevonil (PSL) 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg twice a day (BID) on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. |
| FG001 | Intermediate Metabolizers | Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. |
| FG002 | Poor Metabolizers | Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Characteristics refer to the Safety Set (SS) which consisted of all enrolled participants who received at least 1 dose of Padsevonil (PSL).
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| ID | Title | Description |
|---|---|---|
| BG000 | Extensive Metabolizers | Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of padsevonil (PSL) 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg twice a day (BID) on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of a Single Dose Padsevonil | Cmax is the maximum plasma drug concentration of PSL observed from pharmacokinetic samples taken at predefined time points. | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
|
Treatment emergent adverse events were collected from Baseline until the Safety Follow-up Visit (up to Day 21)
One participant could experience multiple adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Extensive Metabolizers Single Dose (SS) | Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844599 | 2273 | UCBCares@ucb.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2019 | Apr 29, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2020 | Apr 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000708857 | padsevonil |
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Cmax, ss is the maximum plasma concentration of PSL observed from pharmacokinetic samples, taken at predefined time point at a steady-state. |
| Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose |
| Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil | AUCtau is the area under the plasma concentration time curve over a dosing interval. | Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose |
| Terminal Half-life (t1/2) of Multiple Doses Padsevonil | The t1/2 is the apparent terminal half-life. | Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose |
| Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss) | The tmax, ss is the time of observed maximum plasma concentration at a steady-state. | Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose |
| Percentage of Participants With Treatment Emergent Adverse Events During the Study | An Adverse Event (AE) is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. | From Baseline until the Safety Follow-up Visit (up to Day 21) |
| BG001 | Intermediate Metabolizers | Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. |
| BG002 | Poor Metabolizers | Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. |
| BG003 | Total Title |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Intermediate Metabolizers (PK-PPS) | Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS). |
| OG002 | Extensive Metabolizers (PK-PPS) | Extensive metabolizers (Participants confirmed with genotype *1/*1) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. During the Multiple-dose Period, participants received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally. Participants formed the Pharmacokinetic Per Protocol Set (PK-PPS). |
|
|
|
| Primary | Area Under the Curve From 0 to t (AUC(0-t)) of a Single Dose Padsevonil | AUC(0-t) is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
|
|
|
|
| Primary | Area Under the Curve From Time 0 to Infinity (AUC) of a Single Dose Padsevonil | AUC is the area under the plasma concentration-time curve from time zero to infinity. | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
|
|
|
|
| Primary | Terminal Half-life (t1/2) of a Single Dose Padsevonil | The t1/2 is the apparent terminal half-life. Geometric Means and Geometric Coefficient of Variations were only calculated if at least 2/3 of the parameters were properly determined parameters (i.e. non-calculated and non-flagged). | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
|
|
|
| Primary | Time to Reach the Maximum Plasma Concentration (Tmax) of a Single Dose Padsevonil | The tmax is the time to reach maximum plasma concentration. | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Median | Full Range | hours | Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose (up to Day 3) |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Padsevonil at Steady-state (ss) | Cmax, ss is the maximum plasma concentration of PSL observed from pharmacokinetic samples, taken at predefined time point at a steady-state. | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Least Squares Mean | 95% Confidence Interval | ng/mL | Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose |
|
|
|
|
| Primary | Area Under the Curve Over a Dosing Interval (AUCtau) of Multiple Doses Padsevonil | AUCtau is the area under the plasma concentration time curve over a dosing interval. | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Least Squares Mean | 95% Confidence Interval | h*ng/mL | Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose |
|
|
|
|
| Primary | Terminal Half-life (t1/2) of Multiple Doses Padsevonil | The t1/2 is the apparent terminal half-life. | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose |
|
|
|
| Primary | Time to Reach Maximum Concentration (Tmax) for Padsevonil at Steady-state (ss) | The tmax, ss is the time of observed maximum plasma concentration at a steady-state. | The Pharmacokinetic Per-protocol Set (PK-PPS) was a subset of the Safety Set, consisting of those study participants who had no important protocol deviations affecting the PK parameters and for whom a sufficient number of samples were available to determine at least 1 PK parameter. | Posted | Median | Full Range | hours | Day 10: Predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after the morning dose |
|
|
|
| Primary | Percentage of Participants With Treatment Emergent Adverse Events During the Study | An Adverse Event (AE) is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. | The Safety Set (SS) consisted of all study participants who had received at least 1 dose of padsevonil. | Posted | Number | percentage of participants | From Baseline until the Safety Follow-up Visit (up to Day 21) |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 13 |
| 13 |
| EG001 | Intermediate Metabolizers Single Dose (SS) | Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS). | 0 | 13 | 0 | 13 | 13 | 13 |
| EG002 | Poor Metabolizers Single Dose (SS) | Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received a single oral dose of PSL 200 mg in the morning on Day 1 of the Single-dose Period. Participants formed the Safety Set (SS). | 0 | 13 | 0 | 13 | 13 | 13 |
| EG003 | Extensive Metabolizers Multiple Dose (SS) | Extensive metabolizers (Participants confirmed with genotype *1/*1) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS). | 0 | 13 | 0 | 13 | 13 | 13 |
| EG004 | Intermediate Metabolizers Multiple Dose (SS) | Intermediate metabolizers (Participants confirmed with genotype *1/*2,*1/*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS). | 0 | 13 | 0 | 13 | 13 | 13 |
| EG005 | Poor Metabolizers Multiple Dose (SS) | Poor metabolizers (Participants confirmed with genotype *2/*2, *2/*3, *3/*3) received PSL 100 mg BID on Day 6, PSL 200 mg BID from Day 7 to Day 9, PSL 200 mg in the morning on Day 10; PSL 100 mg in the evening on Day 10, and PSL 100 mg BID from Day 11 to Day 12 orally of Multiple-dose Period. Participants formed the Safety Set (SS). | 0 | 13 | 0 | 13 | 13 | 13 |
| Diarrhoea | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA22.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA22.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA22.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA22.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA22.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Poor quality sleep | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA22.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Nightmare | Psychiatric disorders | MedDRA22.1 | Non-systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA22.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA22.1 | Non-systematic Assessment |
|
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| Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation. | ANOVA | The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed. | LS means ratio | 1.289 | 2-Sided | 90 | 1.037 | 1.603 | Other |
| Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation. | ANOVA | The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed. | LS means ratio | 1.646 | 2-Sided | 90 | 1.323 | 2.046 | Other |
| Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation. | ANOVA | The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed. | LS means ratio | 1.291 | 2-Sided | 90 | 1.039 | 1.604 | Other |
| Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation. | ANOVA | The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed. | LS means ratio | 1.645 | 2-Sided | 90 | 1.324 | 2.044 | Other |
| Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation. | ANOVA | The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed. | LS means ratio | 1.044 | 2-Sided | 90 | 0.8489 | 1.283 | Other |
| Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation. | ANOVA | The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed. | LS means ratio | 1.044 | 2-Sided | 90 | 0.8489 | 1.283 | Other |
| Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation. | ANOVA | The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed. | LS means ratio | 0.9991 | 2-Sided | 90 | 0.8120 | 1.229 | Other |
| Point estimates for the geometric least squares (LS) means ratio and the respective 2-sided 90% CIs were computed using the LS means and the root mean squares of error, based on of the log-transformed data with subsequent exponential transformation. | ANOVA | The ANOVA model included genotype group as the fixed effects. The natural logs were taken of the dependent variables and were back-transformed. | LS means ratio | 1.345 | 2-Sided | 90 | 1.093 | 1.655 | Other |