| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 1 Hour | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 1: 1 Hour | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 2 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 1: 2 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 1: 4 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 1: 4 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 4: 0 Hour | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 4: 0 Hour | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 4: 2 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 4: 2 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 0 Hour | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 7: 0 Hour | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 2 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 7: 2 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 4 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 7: 4 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 1 Day 7: 6 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Least Squares Mean | 90% Confidence Interval | milliseconds | | Baseline, Cycle 1 Day 7: 6 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 1: 0 Hour | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Cycle 2 Day 1: 0 Hour | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 1: 2 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Cycle 2 Day 1: 2 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 0 Hour | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Cycle 2 Day 7: 0 Hour | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 2 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Cycle 2 Day 7: 2 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Primary | Change From Baseline in Corrected QT Interval for Heart Rate Using Fridericia's Formula (QTcF) at Cycle 2 Day 7: 6 Hours | Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QT interval was the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTcF was the QT interval corrected for heart rate using Fridericia's formula: QTcF = QT divided by cube root of 60/heart rate. Change from baseline in QT interval corrected for heart rate using Fridericia's formula was reported. | QTc analysis set included all the participants in the safety analysis set who had a baseline ECG and at least 1 post-dose ECG. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | milliseconds | | Baseline, Cycle 2 Day 7: 6 Hours | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Clearance (CL) of Gemtuzumab Ozogamicin | Clearance of a drug was measure of the rate at which the drug was metabolized or eliminated by normal biological processes. | Pharmacokinetic (PK) analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters/hour | | Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Volume of Distribution of Gemtuzumab Ozogamicin | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. | This outcome measure could not be estimated due to insufficient concentration-time data by non-compartmental analysis. | Posted | | | | | | Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax): AC-CL-184538 and CL-184538 | Cmax was defined as the maximum observed plasma concentration of GO. Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analyte were used to determined the Cmax in this outcome measure. | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram/milliliter | | Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Maximum Observed Plasma Concentration (Cmax): Total HP67.6 Antibody | Cmax was defined as the maximum observed plasma concentration of GO. Total HP67.6 antibodies analyte was used to determined the Cmax in this outcome measure. | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter | | Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax = time (hours) to maximum plasma concentration (Cmax). | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. | Posted | | Median | Full Range | hours | | Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast): AC-CL-184538 and CL-184538 | Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUClast). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUClast in this outcome measure. | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram*hour/milliliter | | Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast): Total HP67.6 Antibody | Area under the plasma concentration-time curve from time zero to the time of the last measurable concentration (AUClast). Total HP67.6 antibodies analyte was used to determined the AUClast in this outcome measure. | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter | | Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1; and Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time Zero to Time 72 Hours (AUC0-72): AC-CL-184538 and CL-184538 | Area under the plasma concentration-time curve from time zero to the time 72 hours (AUC0-72). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUC0-72 in this outcome measure. | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram*hour/milliliter | | Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time Zero to Time 72 Hours (AUC0-72): Total HP67.6 Antibody | Area under the plasma concentration-time curve from time zero to the time 72 hours (AUC0-72). Total HP67.6 antibodies analyte was used to determined the AUC0-72 in this outcome measure. | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter | | Pre dose, 1, 2, 4, 6, 24 and 72 hours post dose on Cycle 1 Day 1 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time Zero to Time 336 Hours (AUC0-336): AC-CL-184538 and CL-184538 | Area under the plasma concentration-time curve from time zero to the time 336 hours (AUC0-336). Calicheamicin (conjugated calicheamicin ac-CL-184538 and unconjugated CL-184538) analytes were used to determined the AUC0-336 in this outcome measure. | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Number Analyzed' = participants evaluable for this outcome measure for specified rows. | Posted | | Geometric Mean | Geometric Coefficient of Variation | picogram*hour/milliliter | | Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Area Under the Plasma Concentration-time Profile From Time Zero to Time 336 Hours (AUC0-336): Total HP67.6 Antibody | Area under the plasma concentration-time curve from time zero to the time 336 hours (AUC0-336). Total HP67.6 antibodies analyte was used to determined the AUC0-336 in this outcome measure. | PK analysis set included all the participants who were treated with GO and contributed at least 1 PK sample. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter | | Pre dose, 2, 4, 6, 72, 192 and 336 hours post dose on Cycle 1 Day 7 | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. A treatment emergent AE was defined as an event between first dose of study drug and up to 36 days after the last dose of study drug, that was absent before treatment, or that worsened during the treatment period relative to the pretreatment state. AEs included all serious and non-serious adverse events. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months) | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Number of Participants With Shift From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Laboratory Abnormalities- Hematology and Coagulation Parameters | Laboratory parameters included hematological and coagulation parameters. These included activated partial thromboplastin time prolonged, anemia, fibrinogen decreased, hemoglobin increased, international normalized ratio increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased, white blood cell decreased. Number of participants with hematological and coagulation abnormalities by grades (as per Common Terminology Criteria for Adverse Events (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months) | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Number of Participants With Shift From Grade <=2 at Baseline to Grade 3 or 4 Post-Baseline in Clinical Laboratory Abnormalities- Chemistry Parameters | Laboratory parameters included chemistry parameters. These included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, and hyponatremia. Number of participants with chemistry test abnormalities by grades (CTCAE version 4.03) were reported. Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. | Safety analysis set included all enrolled participants who received at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 36 days after last dose (up to a maximum of 12 months) | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Percentage of Participants With Positive Anti-Drug Antibody (ADA) | Percentage of participants with treatment-induced ADA positive (post baseline-positive only) and treatment-boosted ADA positive (baseline ADA titer that was boosted to a 9-fold or higher level following drug administration) were reported in this outcome measure. | Immunogenicity analysis set included all participants in the safety analysis set who had at least 1 immunogenicity sample with results. | Posted | | Number | | percentage of participants | | From first dose of study drug up to maximum of 12 months | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Percentage of Participants With Positive Neutralizing Antibodies (NAb) | Percentage of participants with either treatment-induced NAb or treatment-boosted NAb were reported. | Immunogenicity analysis set included all participants in the safety analysis set who had at least 1 immunogenicity sample with results. | Posted | | Number | | percentage of participants | | From first dose of study drug up to maximum of 12 months | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Percentage of Participants Who Achieved Complete Remission (CR) and Complete Remission With Incomplete Hematologic Recovery (CRi) | Percentage of participants with first dose of study drug to best overall response with CR and CRi were reported. CR was defined as the disappearance of leukemia indicated by less than (<) 5 percent (%) bone marrow blasts, absence of circulating blasts with auer rods and absence of extramedullary disease, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (>=)1000 per microliter (1000/mcL) and platelets >=100,000/mcL. CRi was defined as all CR criteria except residual neutropenia; ANC <1000/mcL or thrombocytopenia and platelet count <100,000/mcL. | Full analysis set included all enrolled participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From first dose of study drug to 36 days after last dose (maximum up to of 12 months) | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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| Secondary | Overall Survival (OS) | OS was defined as the time (in months) from the start date (first dose) of study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | Full analysis set included all enrolled participants. | Posted | | Median | 95% Confidence Interval | months | | From the first dose of study treatment to the date of death or date of censored, whichever occurred first (maximum up to 12 months) | | | | ID | Title | Description |
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| OG000 | Gemtuzumab Ozogamicin (GO) | Participants with confirmed diagnosis of refractory or relapsed CD33-positive Acute Myeloid Leukemia (AML) aged >= 18 years received three doses of Gemtuzumab Ozogamicin, 3 mg/m^2 as IV infusion on Days 1, 4 and 7 of Cycle 1 and 2. |
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