Trial Outcomes & Findings for Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers (NCT NCT02723630)
NCT ID: NCT02723630
Last Updated: 2019-03-14
Results Overview
Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for \>24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) methodology using a previously validated assay. The lower limit of quantitation (LLOQ) for the assay was 0.25 ng/mL. AUC(0-t) was calculated by the linear-up log-down trapezoidal method. No concentration estimates were provided for missing sample values. Any sample with a missing value was treated as if the sample had not been scheduled for collection.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose
Results posted on
2019-03-14
Participant Flow
Participant milestones
| Measure |
Sequence A
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence A were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level \<4%), Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), and Treatment 3 (high Crystal form Type-C level 38%) on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence B
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence B were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 1 (low Crystal form Type-C level \<4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence C
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence C were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 1 (low Crystal form Type-C level \<4%), and Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence D
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence D were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), and Treatment 1 (low Crystal form Type-C level \<4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence E
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence E were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level \<4%), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence F
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence F were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), Treatment 1 (low Crystal form Type-C level \<4%), and Treatment 3 (high Crystal form Type-C level 38%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
|---|---|---|---|---|---|---|
|
Intervention Period 1
STARTED
|
10
|
10
|
10
|
10
|
10
|
10
|
|
Intervention Period 1
COMPLETED
|
9
|
10
|
10
|
10
|
10
|
10
|
|
Intervention Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 2
STARTED
|
9
|
10
|
10
|
10
|
10
|
10
|
|
Intervention Period 2
COMPLETED
|
9
|
10
|
10
|
10
|
10
|
10
|
|
Intervention Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 3
STARTED
|
9
|
10
|
10
|
10
|
10
|
10
|
|
Intervention Period 3
COMPLETED
|
9
|
9
|
10
|
10
|
10
|
10
|
|
Intervention Period 3
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence A
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence A were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level \<4%), Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), and Treatment 3 (high Crystal form Type-C level 38%) on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence B
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence B were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 1 (low Crystal form Type-C level \<4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence C
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence C were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 1 (low Crystal form Type-C level \<4%), and Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence D
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence D were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), and Treatment 1 (low Crystal form Type-C level \<4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence E
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence E were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level \<4%), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence F
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence F were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), Treatment 1 (low Crystal form Type-C level \<4%), and Treatment 3 (high Crystal form Type-C level 38%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
|---|---|---|---|---|---|---|
|
Intervention Period 1
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Intervention Period 3
consumption of restricted item
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Bioequivalence Study to Evaluate the Impact of Varying Crystalline Polymorph Forms for the Commercial Oral Capsule Formulation of 10-mg Lenvatinib in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Sequence A
n=10 Participants
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence A were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level \<4%), Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), and Treatment 3 (high Crystal form Type-C level 38%) on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence B
n=10 Participants
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence B were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 1 (low Crystal form Type-C level \<4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence C
n=10 Participants
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence C were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 1 (low Crystal form Type-C level \<4%), and Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence D
n=10 Participants
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence D were administered lenvatinib with 240 mL of water in the following sequence; Treatment 3 (high Crystal form Type-C level 38%), Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), and Treatment 1 (low Crystal form Type-C level \<4%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence E
n=10 Participants
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence E were administered lenvatinib with 240 mL of water in the following sequence; Treatment 1 (low Crystal form Type-C level \<4%), Treatment 3 (high Crystal form Type-C level 38%), and Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Sequence F
n=10 Participants
The Randomization Phase consisted of three 6-day long Treatment Periods with each Period separated by a 1-day long Baseline. Sixty participants were evenly randomized to one of 6 possible treatment sequences (A, B, C, D, E, or F). Participants in Sequence F were administered lenvatinib with 240 mL of water in the following sequence; Treatment 2 (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches), Treatment 1 (low Crystal form Type-C level \<4%), and Treatment 3 (high Crystal form Type-C level 38%), on the morning of Days 1, 8, and 15 following an overnight fast of at least 10 hours. No food was allowed for at least 4 hours postdose. Water was allowed ad libitum except for the period beginning 1 hour before and lasting until 1 hour after treatment. Treatments were administered at the same time on the 3 mornings. On dosing days, all participants observed identical schedules with respect to fasting before dosing and timing of postdose meals.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
45.1 Years
STANDARD_DEVIATION 9.55 • n=99 Participants
|
45.1 Years
STANDARD_DEVIATION 10.72 • n=107 Participants
|
36.3 Years
STANDARD_DEVIATION 13.41 • n=206 Participants
|
40.4 Years
STANDARD_DEVIATION 10.80 • n=7 Participants
|
31.7 Years
STANDARD_DEVIATION 10.36 • n=31 Participants
|
37.8 Years
STANDARD_DEVIATION 12.06 • n=30 Participants
|
39.4 Years
STANDARD_DEVIATION 11.77 • n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
8 Participants
n=30 Participants
|
45 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdosePopulation: Pharmacokinetic (PK) analysis set included participants who had sufficient PK data to derive at least one PK parameter. Participants with a predose concentration \>5% Cmax and participants who experienced emesis at or before two times median tmax were excluded from the data analysis.
Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for \>24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) methodology using a previously validated assay. The lower limit of quantitation (LLOQ) for the assay was 0.25 ng/mL. AUC(0-t) was calculated by the linear-up log-down trapezoidal method. No concentration estimates were provided for missing sample values. Any sample with a missing value was treated as if the sample had not been scheduled for collection.
Outcome measures
| Measure |
Treatment 2: Reference Crystal Form
n=59 Participants
Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
|
Treatment 3: High Crystal Form
n=59 Participants
Treatment 3: high Crystal form Type-C level 38%
|
Treatment 1: Low Crystal Form
n=59 Participants
Treatment 1: low Crystal form Type-C level \<4%
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Zero Time (Predose) to Time of Last Quantifiable Concentration (AUC(0-t))
|
1010 ng·hr/mL
Geometric Coefficient of Variation 36.9
|
965 ng·hr/mL
Geometric Coefficient of Variation 39.3
|
1010 ng·hr/mL
Geometric Coefficient of Variation 40.4
|
PRIMARY outcome
Timeframe: Periods 1, 2, and 3; 0 (Predose), 2, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose.Population: PK analysis set
Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for \>24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL. AUC(0-t) was calculated by the linear-up log-down trapezoidal method. AUC(0-inf) was calculate as follows; (AUC(0-inf)) = (AUC(0-t)) + (Ct/Kel), where Ct is the last measurable drug concentration and Kel is the elimination rate constant. The apparent first-order Kel was estimated, when possible, from the slope of the regression line for the terminal ln-linear concentration-time values.
Outcome measures
| Measure |
Treatment 2: Reference Crystal Form
n=57 Participants
Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
|
Treatment 3: High Crystal Form
n=57 Participants
Treatment 3: high Crystal form Type-C level 38%
|
Treatment 1: Low Crystal Form
n=57 Participants
Treatment 1: low Crystal form Type-C level \<4%
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero Time (Predose) Extrapolated to Infinite Time (AUC(0-inf))
|
1020 ng·hr/mL
Geometric Coefficient of Variation 36.9
|
991 ng·hr/mL
Geometric Coefficient of Variation 39.0
|
1030 ng·hr/mL
Geometric Coefficient of Variation 40.0
|
PRIMARY outcome
Timeframe: Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, and 24 hours postdosePopulation: PK analysis set
Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for \>24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.
Outcome measures
| Measure |
Treatment 2: Reference Crystal Form
n=59 Participants
Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
|
Treatment 3: High Crystal Form
n=59 Participants
Treatment 3: high Crystal form Type-C level 38%
|
Treatment 1: Low Crystal Form
n=59 Participants
Treatment 1: low Crystal form Type-C level \<4%
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero Time (Predose) to 24 Hours (AUC(0-24))
|
792 ng·hr/mL
Geometric Coefficient of Variation 39.2
|
740 ng·hr/mL
Geometric Coefficient of Variation 43.5
|
791 ng·hr/mL
Geometric Coefficient of Variation 47.4
|
SECONDARY outcome
Timeframe: Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, and 72 hours postdosePopulation: PK analysis set
Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for \>24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.
Outcome measures
| Measure |
Treatment 2: Reference Crystal Form
n=59 Participants
Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
|
Treatment 3: High Crystal Form
n=59 Participants
Treatment 3: high Crystal form Type-C level 38%
|
Treatment 1: Low Crystal Form
n=59 Participants
Treatment 1: low Crystal form Type-C level \<4%
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve From Zero Time (Predose) to 72 Hours (AUC(0-72))
|
971 ng·hr/mL
Geometric Coefficient of Variation 36.7
|
923 ng·hr/mL
Geometric Coefficient of Variation 39.4
|
975 ng·hr/mL
Geometric Coefficient of Variation 40.5
|
SECONDARY outcome
Timeframe: Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdosePopulation: PK analysis set
Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for \>24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.
Outcome measures
| Measure |
Treatment 2: Reference Crystal Form
n=59 Participants
Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
|
Treatment 3: High Crystal Form
n=59 Participants
Treatment 3: high Crystal form Type-C level 38%
|
Treatment 1: Low Crystal Form
n=59 Participants
Treatment 1: low Crystal form Type-C level \<4%
|
|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Lenvatinib in Plasma
|
97.1 ng/mL
Geometric Coefficient of Variation 49.2
|
88.0 ng/mL
Geometric Coefficient of Variation 57.7
|
96.0 ng/mL
Geometric Coefficient of Variation 64.0
|
SECONDARY outcome
Timeframe: Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdosePopulation: PK analysis set
Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for \>24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.
Outcome measures
| Measure |
Treatment 2: Reference Crystal Form
n=59 Participants
Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
|
Treatment 3: High Crystal Form
n=59 Participants
Treatment 3: high Crystal form Type-C level 38%
|
Treatment 1: Low Crystal Form
n=59 Participants
Treatment 1: low Crystal form Type-C level \<4%
|
|---|---|---|---|
|
Time to Cmax (Tmax) for Lenvatinib
|
3.000 Hours
Interval 1.0 to 12.02
|
3.000 Hours
Interval 2.0 to 12.02
|
3.000 Hours
Interval 1.0 to 12.0
|
SECONDARY outcome
Timeframe: Periods 1, 2, and 3; 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdosePopulation: PK analysis set
Blood samples (6 mL each) were collected at the following time points for each Period: 0 (Predose), 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, and 120 hours postdose. The window for 0 to 12 hours was +/-2 minutes, for 24 hours was +/-5 minutes and for \>24 hours was equal to +/-15 to 60 minutes. Plasma concentrations of lenvatinib were quantified by LC-MS/MS methodology using a previously validated assay. The LLOQ for the assay was 0.25 ng/mL.
Outcome measures
| Measure |
Treatment 2: Reference Crystal Form
n=59 Participants
Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
|
Treatment 3: High Crystal Form
n=57 Participants
Treatment 3: high Crystal form Type-C level 38%
|
Treatment 1: Low Crystal Form
n=59 Participants
Treatment 1: low Crystal form Type-C level \<4%
|
|---|---|---|---|
|
Terminal Elimination Phase Half-life (t1/2)
|
24.2 Hours
Standard Deviation 6.23
|
23.5 Hours
Standard Deviation 6.61
|
24.1 Hours
Standard Deviation 6.88
|
SECONDARY outcome
Timeframe: From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 monthsPopulation: Safety analysis set (SAS) included the group of participants who received at least one dose of study drug and had at least one postdose safety assessment.
Safety assessments consisted of monitoring and recording all adverse events (AEs) (serious and non-serious); regular monitoring of hematology, blood chemistry and urine values; periodic measurement of vital signs and electrocardiograms, performance of physical examinations. A TEAE was defined as an AE that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. TEAEs considered by the investigator to be possibly or probably related to study drug, or TEAEs with missing causality, were included.
Outcome measures
| Measure |
Treatment 2: Reference Crystal Form
n=59 Participants
Treatment 2: reference (reference range determined from clinical batches) Crystal form Type-C level 15%
|
Treatment 3: High Crystal Form
n=59 Participants
Treatment 3: high Crystal form Type-C level 38%
|
Treatment 1: Low Crystal Form
n=59 Participants
Treatment 1: low Crystal form Type-C level \<4%
|
|---|---|---|---|
|
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability of Lenvatinib
TEAEs
|
23.7 Percentage of participants
|
20.3 Percentage of participants
|
23.7 Percentage of participants
|
|
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability of Lenvatinib
Treatment-related TEAEs
|
15.2 Percentage of participants
|
16.9 Percentage of participants
|
18.6 Percentage of participants
|
|
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability of Lenvatinib
Severe TEAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
1.69 Percentage of participants
|
|
Number of Participants With Non-Serious Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events as a Measure of Safety and Tolerability of Lenvatinib
Serious TEAEs
|
0 Percentage of participants
|
0 Percentage of participants
|
1.69 Percentage of participants
|
Adverse Events
Treatment 1: Low Crystal Form
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Treatment 2: Reference Crystal Form
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Treatment 3: High Crystal Form
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment 1: Low Crystal Form
n=59 participants at risk
Treatment 1: (low Crystal form Type-C level \<4%)
|
Treatment 2: Reference Crystal Form
n=59 participants at risk
Treatment 2: (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches)
|
Treatment 3: High Crystal Form
n=59 participants at risk
Treatment 3: (high Crystal form Type-C level 38%)
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.7%
1/59 • Number of events 1 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
Other adverse events
| Measure |
Treatment 1: Low Crystal Form
n=59 participants at risk
Treatment 1: (low Crystal form Type-C level \<4%)
|
Treatment 2: Reference Crystal Form
n=59 participants at risk
Treatment 2: (reference\* Crystal form Type-C level 15%, \*reference range determined from clinical batches)
|
Treatment 3: High Crystal Form
n=59 participants at risk
Treatment 3: (high Crystal form Type-C level 38%)
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
General disorders
Oedema peripheral
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
General disorders
Pain
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Infections and infestations
Rash pustular
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Investigations
Blood bilirubin increased
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Investigations
Blood phosphorus increased
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Investigations
Blood pressure increased
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Metabolism and nutrition disorders
Increased appetite
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Nervous system disorders
Burning sensation
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Nervous system disorders
Dizziness
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Nervous system disorders
Headache
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
6.8%
4/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
10.2%
6/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Nervous system disorders
Restless legs syndrome
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Nervous system disorders
Syncope
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Psychiatric disorders
Hypervigilance
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Skin and subcutaneous tissue disorders
Papule
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
2/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.7%
1/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
0.00%
0/59 • From date of first dose up to 30 days after the last dose of study treatment, up to approximately 2 months
Treatment-emergent adverse events (TEAEs) were reported. TEAEs were defined as an adverse event (AE) that emerges during treatment, having been absent at pretreatment (Baseline), or reemerges during treatment, having been present at pretreatment but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the AE is continuous. AEs were graded on a 3-point scale (mild, moderate, severe). All serious AEs were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER