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Administrative reason
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This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.
This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.
Cohorts of 8 participants each (6 active, 2 placebo) will be sequentially administered verdinexor or placebo (one dose on Day 1 and one dose on Day 3) using a dose-escalation scheme. A conservative, sequential, dose-escalation strategy employing decreasing escalation increments will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3. |
|
| Verdinexor 5 mg | Experimental | Participants received verdinexor 5 milligrams (mg) (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3. |
|
| Verdinexor 10 mg | Experimental | Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3. |
|
| Verdinexor 20 mg | Experimental | Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3. |
|
| Verdinexor 40 mg | Experimental | Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verdinexor | Drug | Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur after participant's signed informed consent obtained. A serious adverse event (SAE) was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) that and regardless of causality that: results in death, was life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 30 days following last dose or any event considered drug-related by the investigator through the end of the study. | From start of study drug administration up to Day 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Verdinexor | AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Melbourne | Victoria | Australia |
A total of 33 participants were enrolled and randomized, of which 1 participant randomized to verdinexor 20 milligrams (mg) arm discontinued the study before the start of the treatment (due to Adverse event [AE] prior to the pre-dose assessment). Total 32 participants started the study treatment.
This study was conducted at single site in Australia from 26 May 2015 to 1 October 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3. |
| FG001 | Verdinexor 5 mg | Participants received verdinexor 5 milligrams (mg) (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3. |
| FG002 | Verdinexor 10 mg | Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3. |
| FG003 | Verdinexor 20 mg | Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3. |
| FG004 | Verdinexor 40 mg | Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety Population included all participants who received at least one dose of verdinexor or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3. |
| BG001 | Verdinexor 5 mg | Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An AE was defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur after participant's signed informed consent obtained. A serious adverse event (SAE) was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) that and regardless of causality that: results in death, was life-threatening (participant was at immediate risk of death from event as it occurred), requires in-patient hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect. TEAE was defined as any AE with onset or worsening of a pre-existing condition on or after the first administration of study treatment through 30 days following last dose or any event considered drug-related by the investigator through the end of the study. | Safety population included all participants who received at least 1 dose of verdinexor or placebo. | Posted | Count of Participants | Participants | From start of study drug administration up to Day 33 |
From start of study drug administration up to Day 33
Safety population included all participants who received at least 1 dose of verdinexor or placebo.
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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 | Placebo | Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
This study was terminated due to administrative reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jatin Shah, MD | Karyopharm Therapeutics Inc | (617) 658-0600 | jshah@karyopharm.com |
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| ID | Term |
|---|---|
| C000593855 | verdinexor |
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|
| Placebo | Other | Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral |
|
| Area Under the Concentration-time Curve From Time Zero to Extrapolated to Infinity (AUC0-inf) of Verdinexor |
AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated). It was calculated as AUC0-t + Ct/kel, where: Ct = the last observed non-zero concentration, kel = elimination rate constant. |
| Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Maximum Observed Concentration (Cmax) of Verdinexor | Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Average Plasma Concentration From Time Zero to 24 Hours Post-dose (Cavg0-24h) of Verdinexor | Cavg0-24h was defined as average plasma concentration from time zero to 24 hours post-dose. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours post-dose |
| Time of First Observation of Maximum Observed Concentration (Tmax) of Verdinexor | Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Elimination Rate Constant (Kel) of Verdinexor | Elimination rate constant was calculated using linear regression on the terminal portion of the log-linear concentration versus time curve. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Elimination Half-life (t1/2) of Verdinexor | t1/2 was defined as elimination half-life, it was calculated as ln(2)/kel. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Apparent Total Body Clearance (Cl/F) of Verdinexor | Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram [kg]). | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Apparent Volume of Distribution (Vd/F) of Verdinexor | Vd/F was calculated as Dose/ (kel *AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg). | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Accumulation Factor (AR) of Cmax | An AR was defined as a ratio of mean of Cmax Day 3/ Cmax Day 1 for plasma verdinexor. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Accumulation Factor (AR) of Cavg0-24Hour | An AR was defined as a ratio of mean of Cavg0-24hour Day 3/ Cavg0-24hour Day 1 for plasma verdinexor. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours post-dose |
| Accumulation Factor (AR) of AUC0-t | An AR factor was defined as a ratio of mean of AUC0-t Day 3/ AUC0-t Day 1 for plasma verdinexor. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Accumulation Factor (AR) of AUC0-inf | Accumulation factor was defined as a ratio of mean of AUC0-inf Day 3/ AUC0-inf Day 1 for plasma verdinexor. | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
| Maximum Tolerated Dose (MTD) of Verdinexor | MTD was defined as the dose level tested in the cohort immediately preceding a cohort where one or more dose limiting toxicities (DLTs) were observed. A DLT was defined as any AE or abnormal laboratory value that the Investigator suspected was probably related to verdinexor that was severe in intensity or serious or Indicative of an unacceptable risk to additional participants in the study in the opinion of the Investigator or Sponsor. | From start of study drug administration up to Day 8 |
| Randomized but never treated |
|
| BG002 | Verdinexor 10 mg | Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3. |
| BG003 | Verdinexor 20 mg | Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3. |
| BG004 | Verdinexor 40 mg | Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Placebo | Participants received matched placebo tablets to verdinexor tablets orally once daily on Days 1 and 3. |
| OG001 | Verdinexor 5 mg | Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3. |
| OG002 | Verdinexor 10 mg | Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3. |
| OG003 | Verdinexor 20 mg | Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3. |
| OG004 | Verdinexor 40 mg | Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3. |
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to the Last Non-zero Concentration (AUC0-t) of Verdinexor | AUC0-t was defined as area under the concentration-time curve from time zero to the last non-zero concentration | Pharmacokinetic (PK) population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the limit of quantification [LOQ]) post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng*h/mL) | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time Zero to Extrapolated to Infinity (AUC0-inf) of Verdinexor | AUC0-inf was defined as area under the concentration-time curve from time zero to infinity (extrapolated). It was calculated as AUC0-t + Ct/kel, where: Ct = the last observed non-zero concentration, kel = elimination rate constant. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | ng*h/mL | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
|
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|
| Secondary | Maximum Observed Concentration (Cmax) of Verdinexor | Cmax was defined as maximum observed concentration, taken directly from the plasma concentration data. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
|
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| Secondary | Average Plasma Concentration From Time Zero to 24 Hours Post-dose (Cavg0-24h) of Verdinexor | Cavg0-24h was defined as average plasma concentration from time zero to 24 hours post-dose. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | ng/mL | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours post-dose |
|
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| Secondary | Time of First Observation of Maximum Observed Concentration (Tmax) of Verdinexor | Tmax was defined as time of first observation of Cmax, taken directly from the plasma concentration data. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Median | Full Range | hours | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
|
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| Secondary | Elimination Rate Constant (Kel) of Verdinexor | Elimination rate constant was calculated using linear regression on the terminal portion of the log-linear concentration versus time curve. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ) post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | per hour (1/h) | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
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| Secondary | Elimination Half-life (t1/2) of Verdinexor | t1/2 was defined as elimination half-life, it was calculated as ln(2)/kel. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | hours | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
|
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| Secondary | Apparent Total Body Clearance (Cl/F) of Verdinexor | Apparent total body clearance was calculated as Dose/AUC0-inf, uncorrected for fraction absorbed; reported normalized by participant body weight (kilogram [kg]). | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | liter per hour per kilogram (L/h/kg) | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
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| Secondary | Apparent Volume of Distribution (Vd/F) of Verdinexor | Vd/F was calculated as Dose/ (kel *AUC0-inf), uncorrected for fraction absorbed; reported normalized by participant body weight (kg). | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here, 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Mean | Standard Deviation | liter per kilogram (L/kg) | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
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| Secondary | Accumulation Factor (AR) of Cmax | An AR was defined as a ratio of mean of Cmax Day 3/ Cmax Day 1 for plasma verdinexor. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Number | Ratio | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
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| Secondary | Accumulation Factor (AR) of Cavg0-24Hour | An AR was defined as a ratio of mean of Cavg0-24hour Day 3/ Cavg0-24hour Day 1 for plasma verdinexor. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Number | Ratio | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24 hours post-dose |
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| Secondary | Accumulation Factor (AR) of AUC0-t | An AR factor was defined as a ratio of mean of AUC0-t Day 3/ AUC0-t Day 1 for plasma verdinexor. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Number | Ratio | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
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| Secondary | Accumulation Factor (AR) of AUC0-inf | Accumulation factor was defined as a ratio of mean of AUC0-inf Day 3/ AUC0-inf Day 1 for plasma verdinexor. | PK population included all participants who received at least 1 dose of verdinexor, had a pre-dose (baseline) blood draw, and had at least 1 qualified (above the LOQ post-dose PK sample. Here 'number analyzed' signifies number of participants evaluable at specific time points. | Posted | Number | Ratio | Days 1 and 3: pre-dose, 15 minutes, 30 minutes, 1, 2, 3, 4, 8, 12, 24, 48 (only for Day 3) hours post-dose |
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| Secondary | Maximum Tolerated Dose (MTD) of Verdinexor | MTD was defined as the dose level tested in the cohort immediately preceding a cohort where one or more dose limiting toxicities (DLTs) were observed. A DLT was defined as any AE or abnormal laboratory value that the Investigator suspected was probably related to verdinexor that was severe in intensity or serious or Indicative of an unacceptable risk to additional participants in the study in the opinion of the Investigator or Sponsor. | MTD was not achieved at study completion due to early termination of study prior to observing protocol-specified DLT criteria. Therefore, no data was reported for this outcome measure. | Posted | From start of study drug administration up to Day 8 |
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| 0 |
| 8 |
| 0 |
| 8 |
| 5 |
| 8 |
| EG001 | Verdinexor 5 mg | Participants received verdinexor 5 mg (2 tablets of 2.5 mg each) orally once daily on Days 1 and 3. | 0 | 6 | 0 | 6 | 6 | 6 |
| EG002 | Verdinexor 10 mg | Participants received verdinexor 10 mg tablet orally once daily on Days 1 and 3. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Verdinexor 20 mg | Participants received verdinexor 20 mg tablet (2 tablets of 10 mg each) orally once daily on Days 1 and 3. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG004 | Verdinexor 40 mg | Participants received verdinexor 40 mg tablet (4 tablets of 10 mg each) orally once daily on Days 1 and 3. | 0 | 6 | 0 | 6 | 5 | 6 |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (18.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Spermatozoa morphology abnormal | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Spermatozoa progressive motility decreased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (18.0) | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (18.0) | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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Not provided
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