| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | nanograms per milliliter (ng/mL) | | Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. | | OG002 | Age Cohort: >=2 to <6 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. | | OG003 | Age Cohort : >=1 Month to <2 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
| | Units | Counts |
|---|
| Participants | - OG00012
- OG00110
- OG00210
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000149.0(27.6 to 805.1)
- OG001NA(NA to NA)Geometric mean and 95% CI were only calculated if at least two-thirds of the data were greater than the lower Limit of quantification (LOQ).
- OG002
|
|
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
|
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
|
| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 4 in >=12 to <16 years, >=2 to <6 years, and >=1 to <2 years patients. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
|
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 4 in >=12 to <16 years, >=2 to <6 years, and >=1 to <2 years patients. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
|
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 4 in >=12 to <16 years, >=2 to <6 years, and >=1 to <2 years patients. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
|
| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 5 in >=12 to <16 years patients. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
|
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 5 in >=12 to <16 years patients. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
|
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. PK samples were not collected at Visit 5 in >=12 to <16 years patients. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Age Cohort: >=12 to <16 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the Pharmacokinetic Per-protocol Set (PK-PPS). | | OG001 | Age Cohort: >=6 to <12 Years (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining as a bolus (up to 2-minute infusion). Participants formed the PK-PPS. |
|
| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration - 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- 15 Minutes | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | 15-minute Infusion (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6 days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion. Participants formed the PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 3 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
| |
| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 3 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
|---|
| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
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| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 3 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 3 (Day 1 of IV PK period) | | | | ID | Title | Description |
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| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
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| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 4 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. PK samples were not collected at Visit 4 in bolus patients. | Posted | | | | | | At <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
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| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
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| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 4 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. PK samples were not collected at Visit 4 in bolus patients. | Posted | | | | | | At 15 minutes post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
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| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
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| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 4 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. PK samples were not collected at Visit 4 in bolus patients. | Posted | | | | | | At 3 hours post-initiation of iv BRV infusion at Visit 4 (Day 2 of IV PK period) | | | | ID | Title | Description |
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| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
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| Primary | Plasma Concentration of Brivaracetam (BRV) at Predose (<=1 Hour), Visit 5 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at <= 1 hour pre-initiation of intravenous (iv) BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
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| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
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| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 15 Minutes, Visit 5 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 15 minutes post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
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| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
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| Primary | Plasma Concentration of Brivaracetam (BRV) at Postdose 3 Hours, Visit 5 by Infusion Duration- Bolus | Blood samples were taken at indicated time points to determine brivaracetam (BRV) plasma concentration before, during, and after iv BRV administration. | The PK-PPS included all study participants in the SS-iv having provided at least 1 measurable postdose plasma sample (with recorded sampling time) during the iv PK Period with documented iv BRV infusion times and without IPDs impacting the interpretability of the PK analyses. Here, N (number of participants analyzed) were included who were evaluable for the assessment. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Blood samples were collected at 3 hours post-initiation of iv BRV infusion at Visit 5 (Day 2 of IV PK period) | | | | ID | Title | Description |
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| OG000 | Bolus (PK-PPS) | Participants received iv administration of BRV every 12 hours during the IV PK Period (1-6days). For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort the second half received the bolus (up to 2-minute infusion). Participants formed PK-PPS. |
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| Primary | Number of Participants With Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. | The SS-iv included study participants who received at least 1 dose of iv BRV. | Posted | | Count of Participants | | Participants | | From Screening until last visit (up to Day 68) | | | | ID | Title | Description |
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| OG000 | Age Cohort: >=12 to <16 Years (SS-iv) | Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety Set-Intravenous (SS-iv). | | OG001 | Age Cohort: >=6 to <12 Years (SS-iv) | Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv. |
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| Primary | Number of Participant Withdrawals Due to Adverse Events | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. | The SS-iv included study participants who received at least 1 dose of iv BRV. | Posted | | Count of Participants | | Participants | | From Screening until last visit (up to Day 68) | | | | ID | Title | Description |
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| OG000 | Age Cohort: >=12 to <16 Years (SS-iv) | Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the Safety Set-Intravenous (SS-iv). | | OG001 | Age Cohort: >=6 to <12 Years (SS-iv) | Screening Period (1-10 days): Participants receiving OLB or RxB continued to receive oral BRV. IOB Treatment Period (2-10 days): IOB Participants continued with oral BRV 2mg/kg/day. IV PK Period (1-6 days): During iv PK Period, iv BRV was administered every 12 hours. For OLB, RxB, and IOB participants, first iv BRV dose was equivalent to final dose of oral BRV and for IIB participants, first iv BRV dose was 1mg/kg. For each cohort, the first half received the 15-minute infusion, the remaining half as a bolus (up to 2-minute infusion). Down-Titration Period: Participants who discontinued treatment, had their BRV dose reduced every week for a maximum of 4 weeks down to a dose of 1mg/kg/day. Participants formed the SS-iv. |
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