| Primary | Area Under the Curve (AUC) of Respiratory Syncytial Virus (RSV) Viral Load | AUC of RSV viral load was measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) assay of the mid-turbinate nasal swab. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Day 1 to 7: Predose, 0.25 and 2 hours postdose | | | | ID | Title | Description |
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| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Number of Participants With Emergent Adverse Event | 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 the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. All AEs reported during treatment or follow-up were considered emergent and were included in the analysis. | Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. |
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| Secondary | Number of Participants With Clinically Significant Physical Examinations Abnormalities | The number of participants with clinically significant physical examination (respiratory system, nose, ear, throat, facial and neck lymph nodes, and skin examination) abnormalities that emerged after treatment initiation was reported. | Randomized or Treated set was defined as all participants who were in Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all participants treated (AST) set. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 |
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| Secondary | Number of Participants With Emergent Clinical Relevant Vital Signs Abnormalities | The number of participants with emergent clinically relevant vital signs (temperature, pulse rate, respiratory rate, diastolic blood pressure, systolic blood pressure, oxygen saturation) abnormalities that emerged after treatment initiation reported. An abnormality was considered emergent in a particular phase if it is worse than baseline. If baseline is missing, the abnormality is always considered as emergent. A shift from 'abnormally low' at baseline to 'abnormally high' post baseline (or vice versa) was also emergent. | Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | |
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| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormalities | The number of participants with ECG (QT, and QTc intervals) abnormalities reported. | Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Number of Participants With Worst Emergent Laboratory Abnormalities (Division of Microbiology and Infectious Diseases [DMID] Toxicity Grades) | Number of participants with Laboratory (hematology, serum chemistry, and urinalysis) abnormalities reported based on DMID toxicity grading scale. DMID toxicity grades ranges from 1 to 4. Grade 0 is normal and not meeting the criteria of Grade 1-4. Hb: Grade 1: for 22-35 days old- 9.5-10.5 gram per deciliter (g/dL); for 36-60 days old- 8.5-9.4 g/dL; for 61-90 days old- 9.0-9.9 g/dL; Hb: Grade 2: for 22-35 days old- 8.0-9.4 g/dL, for 36-60 days old- 7.0-8.4 g/dL; for 61-90 days old- 7.0-8.9 g/dL. ALT: Grade 1- 1.1 - <2.0*Upper limit of normal (ULN); Creatinine: Grade 2- 1.8-2.4 milligram per deciliter (mg/dL); Hyperkalemia: Grade 1- 3.0-3-5 milliequivalents per Liter (mEq/L); ANC: Grade 1: for 7-60 days old- 1200-1800/ millimeter cube(mm^3); for 61-90 days old- 750-1200/mm^3; ANC: Grade 3: for 7-60 days old- 500-899/mm^3, for 61-90 days old- 250-399/mm^3; ANC: Grade 4- for 7-60 days old <500/mm^3, for 61-90 days old- <250/mm^3; Platelets: Grade 3: 25000 - 49999/mm^3. | Safety analysis set was defined as all participants who received at least 1 dose of study drug, analyzed as treated. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 (Metabolite of Lumicitabine) | Cmax is the maximum observed plasma concentration of JNJ-63549109 (Metabolite of Lumicitabine). | Intent to Treat (ITT) set was defined as all randomized participants who receive at least 1 dose of study. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/ml) | | Day 1 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG001 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Area Under Plasma Concentration-time Curve (AUC) of JNJ-63549109 (Metabolite of Lumicitabine) | AUC is the area under the plasma concentration-time curve of JNJ-63549109 (Metabolite of Lumicitabine). | ITT set was defined as all randomized participants who receive at least 1 dose of study. | Posted | | Mean | Standard Deviation | nanogram hour per milliliters (ng*h/ml) | | Day 1 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG001 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Trough Observed Analyte Concentration (C[Trough]) of JNJ-63549109 (Metabolite of Lumicitabine) | C(trough) is the plasma concentration before dosing or at the end of the dosing interval of any dose other than the first dose in a multiple dosing regimen of JNJ-63549109 (Metabolite of Lumicitabine). | ITT set was defined as all randomized participants who receive at least 1 dose of study. | Posted | | Mean | Standard Deviation | ng/ml | | Day 1 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG001 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Predicted Concentration of JNJ-63549109 (Metabolite of Lumicitabine) at 12 Hours Postdose (C12h) | C12h is the predicted concentration of JNJ-63549109 at 12 hours Postdose. C12h is a model-based prediction. It was determined using a population pharmacokinetic (PK) model and based on the individual model predicted concentration-time profiles. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | 12 hours postdose | | | | ID | Title | Description |
|---|
| OG000 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG001 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Length of Hospital Stay | Length of hospital stay is defined as the time from hospitalization to actual hospital discharge. | Population included randomized or treated set. As the study was early terminated with fewer participants than planned, results for this endpoint could not be summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm. | Posted | | Number | | Hours | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Number of Participants Admitted to the Intensive Care Unit (ICU) | Number of participants who were admitted to the ICU was reported. | Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Duration of ICU Stay | In the event that a participant required ICU, the duration for how long the participant remained in the ICU was reported. | No participant was admitted to ICU hence results could not be determined for this outcome measure. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Number of Participants Who Required Supplemental Oxygen | The number of participants who required supplemental oxygen above pre-RSV infection status was reported. | Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Number of Participants Who Required Non-invasive Mechanical Ventilation Support | The number of participants who required non-invasive mechanical ventilation support (that is, continuous positive airway pressure) above pre-RSV infection status was reported. | Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD |
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| Secondary | Number of Participants Who Required Invasive Mechanical Ventilation Support | The number of participants who required invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) above pre-RSV infection status was reported. | Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD |
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| Secondary | Duration of Supplemental Oxygen | Duration of supplemental oxygen above pre-RSV infection status was assessed. | Population included randomized or treated set who received supplemental oxygen. | Posted | | Number | | Hours | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Duration of Non-invasive Mechanical Ventilation Support | Duration of non-invasive mechanical ventilation support (that is, continuous positive airway pressure) to deliver oxygen above pre-RSV infection status was measured. | No participant received non-invasive mechanical ventilation support hence results could not be drawn for this outcome measure. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Duration of Invasive Mechanical Ventilation Support | Duration of invasive mechanical ventilation support (for example, endotracheal-mechanical ventilation or mechanical ventilation via tracheostomy) to deliver oxygen above pre-RSV infection status was measured. | No participant received invasive mechanical ventilation support hence results could not be drawn for this outcome measure. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Time to no Longer Requiring Supplemental Oxygen | Time to no longer requiring supplemental oxygen above pre-RSV infection status was reported. | Population included randomized or treated set who received supplemental oxygen. | Posted | | Number | | Hours | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Time to Clinical Stability | Time to clinical stability was defined as the time at which the following criteria are all met: normalization of blood oxygen level (return to baseline, by pulse oximetry) without the requirement of supplemental oxygen beyond baseline level, normalization of oral feeding, normalization of respiratory rate, and normalization of heart rate. | Population included randomized or treated set. Due to early study termination and less number of participants collected data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm. | Posted | | Number | | Hours | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD |
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| Secondary | Time From Initiation of Study Treatment Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=)93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to Onset of Respiratory Symptoms | Time from initiation of study treatment until SpO2 >=93% on room air among participants who were not on supplemental oxygen prior to the onset of respiratory symptoms was reported. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Time for Respiratory Rate to Return to Pre-RSV Infection Status | Time for the respiratory rate to return to pre-RSV infection status was measured. | Population included randomized or treated set. As study was terminated early with fewer participants than planned, results for this endpoint could not be summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm. | Posted | | Number | | Hours | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Time for SpO2 to Return to Pre-RSV Infection Status | Time for SpO2 to return to pre-RSV infection status was measured. | Population included randomized or treated set. As study was terminated early with fewer participants than planned, data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm. | Posted | | Number | | Hours | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Time for Body Temperature to Return To Pre-RSV Infection Status | Time for body temperature to return to pre-RSV infection status was measured. | Population included randomized or treated set. As study was terminated early with fewer participants than planned, data was not summarized. Hence, individual data for each participant was reported. Here, n (number analyzed) signifies specific participant evaluated in respective arm. | Posted | | Number | | Hours | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Number of Participants With Acute Otitis Media | Number of participants with acute otitis media was reported. | Randomized or Treated set was defined as all participants who were in the Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or the AST set. | Posted | | Count of Participants | | Participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Duration of Signs and Symptoms of RSV Infection | Duration of signs and symptoms of RSV infection was assessed. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Severity of Signs and Symptoms of RSV Infection Assessed by the Pediatric RSV Electronic Severity and Outcome Rating System (PRESORS) | The severity of signs and symptoms of RSV infection were assessed by the PRESORS. PRESORS Score consisted of 5-items, each score ranges from 0 to 3 and the total score was analyzed by summing up the individual score ranging from 0 (minimum; best) to 15 (maximum; worse). | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | RSV Viral Load Over Time | RSV viral load over time was measured by qRT-PCR in the mid-turbinate nasal swab specimens. | Intention-To-Treat-infected (ITT-i) set was defined as all randomly assigned participants who receive at least 1 dose of study drug and who have an RSV infection confirmed by a polymerase chain reaction (PCR)-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory. | Posted | | Mean | Standard Deviation | log10 per milliliters (log10/mL) | | On Day 2, 3, 4, 5, 6, 7, 10, 14 and 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Peak Viral Load | Peak viral load was measured by qRT-PCR in the mid-turbinate nasal swab specimens. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Time To Peak Viral Load | Time to peak viral load was reported. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Percentage of Participants With Decline of Viral Load | Percentage of participants with decline in viral load during treatment as measured by qRT-PCR was reported. | ITT-i set was defined as all randomly assigned participants who receive at least 1 dose of study drug and who have an RSV infection confirmed by a PCR-based assay at baseline or within 1 hour after the first study medication intake at the central laboratory. | Posted | | Number | | Percentage of participants | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Time to RSV Ribonucleic Acid (RNA) Being Undetectable | Time to RSV RNA being undetectable (the time from initiation of study treatment until the time at which it is observed that the virus is undetectable in an assessment and after which time no virus positive assessment follows) was assessed as measured by qRT-PCR. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Percentage of Participants With Undetectable RSV Viral Load | Percentage of participants with the undetectable viral load was reported. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | AUC of RSV RNA Viral Load From Baseline up to Day 10 | AUC of RSV RNA viral load was measured in mid-turbinate nasal swabs and in the endotracheal sample. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Baseline up to Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | AUC of RSV RNA Viral Load From Baseline up to Day 14 | AUC of RSV RNA viral load was measured in midturbinate nasal swabs and in endotracheal samples. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Baseline up to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | AUC of RSV Viral Load From Baseline Until 1 Day After the Last Dose of Study Drug | AUC of RSV viral load was measured in midturbinate nasal swabs and in endotracheal samples. | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Baseline Until 1 Day after the last dose of study drug (up to 10 days) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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| Secondary | Number of Participants With Emergent Postbaseline Changes in the RSV Polymerase L-gene and Other Regions of the RSV Genome Compared With Baseline Sequences | Number of participants with emergent postbaseline changes in the RSV polymerase L-gene and other regions of the RSV genome compared with baseline sequences were reported. | Randomized or Treated set was defined as all participants who were in Randomized Analysis Set (all randomized participants with a randomization date at or before the date of the first intake of medication, or with a randomization date and a missing date for first medication intake, analyzed as randomized) and/or all participants treated (AST) set. | Posted | | Count of Participants | | Participants | | Baseline up to 28 days | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 |
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| Secondary | Acceptability and Palatability of Lumicitabine Formulation as Assessed by Clinician Electronic Clinical Outcome Assessment (eCOA) | Acceptability and Palatability of lumicitabine formulation was assessed by clinician eCOA questionnaire ranging from score 0 (minimum; best) to 8 (maximum; worse). | As study was terminated early with fewer participants than planned, data for this outcome measure was not collected and analyzed. | Posted | | | | | | Up to Day 6 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received a single dose of lumicitabine-40 milligrams/kilogram (mg/kg) matched placebo as a loading dose (LD) (Dose 1) followed by 9 maintenance dose (MD) of lumicitabine-20 mg/kg matched placebo twice a day or a single dose of lumicitabine-60 mg/kg matched placebo LD (Dose 1) followed by nine lumicitabine-40 mg/kg matched placebo MD (Dose 2 to 10). | | OG001 | Lumicitabine 40/20 mg/kg LD/MD | Participants received a single dose of lumicitabine-40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | Participants received a single dose of lumicitabine-60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day. |
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