Trial Outcomes & Findings for Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men (NCT NCT02236988)
NCT ID: NCT02236988
Last Updated: 2021-06-01
Results Overview
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.
Results posted on
2021-06-01
Participant Flow
This study was conducted at a single study site in the United States from July 2013 to September 2014.
This was an open-label crossover study that consisted of 4 groups of participants and tested 12 different modified release (MR) formulations of apremilast versus the reference immediate release (IR) formulation. Within each group participants were randomized to a treatment sequence.
Participant milestones
| Measure |
Group 1
Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3
|
Group 2
Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
|
Group 3
Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
|
Group 4
Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
18
|
30
|
|
Overall Study
COMPLETED
|
16
|
16
|
18
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Group 1
Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3
|
Group 2
Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
|
Group 3
Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
|
Group 4
Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Unable to Comply with Study Visits
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men
Baseline characteristics by cohort
| Measure |
Group 1
n=16 Participants
Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3
|
Group 2
n=16 Participants
Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
|
Group 3
n=18 Participants
Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
|
Group 4
n=30 Participants
Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
39.1 years
n=5 Participants
|
34.1 years
n=7 Participants
|
30.4 years
n=5 Participants
|
33.3 years
n=4 Participants
|
34.0 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
26.82 kg/m^2
n=5 Participants
|
25.56 kg/m^2
n=7 Participants
|
24.83 kg/m^2
n=5 Participants
|
25.15 kg/m^2
n=4 Participants
|
25.49 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The pharmacokinetic (PK) population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Observed Maximum Plasma Concentration (Cmax) of Apremilast
|
409.96 ng/mL
Geometric Coefficient of Variation 34.9
|
267.85 ng/mL
Geometric Coefficient of Variation 56.4
|
329.78 ng/mL
Geometric Coefficient of Variation 52.2
|
345.11 ng/mL
Geometric Coefficient of Variation 41.5
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast
|
6918.49 ng*h/mL
Geometric Coefficient of Variation 47.7
|
4277.83 ng*h/mL
Geometric Coefficient of Variation 88.2
|
4925.69 ng*h/mL
Geometric Coefficient of Variation 67.7
|
5103.07 ng*h/mL
Geometric Coefficient of Variation 54.3
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast
|
6955.76 ng*h/mL
Geometric Coefficient of Variation 47.9
|
4330.66 ng*h/mL
Geometric Coefficient of Variation 88.2
|
4961.51 ng*h/mL
Geometric Coefficient of Variation 67.8
|
5147.83 ng*h/mL
Geometric Coefficient of Variation 54.5
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast
|
3.00 hours
Interval 2.0 to 5.0
|
4.00 hours
Interval 2.0 to 8.0
|
4.00 hours
Interval 2.0 to 8.0
|
4.00 hours
Interval 3.0 to 14.0
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Half-life of Apremilast in Terminal Phase (T1/2)
|
7.12 hours
Geometric Coefficient of Variation 23.3
|
7.43 hours
Geometric Coefficient of Variation 21.7
|
6.88 hours
Geometric Coefficient of Variation 22.0
|
7.29 hours
Geometric Coefficient of Variation 21.8
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Apparent Total Plasma Clearance (CL/F) of Apremilast
|
8.63 L/h
Geometric Coefficient of Variation 47.9
|
17.32 L/h
Geometric Coefficient of Variation 88.2
|
15.12 L/h
Geometric Coefficient of Variation 67.8
|
14.57 L/h
Geometric Coefficient of Variation 54.5
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Apparent Total Volume of Distribution (Vz/F) of Apremilast
|
88.65 liters
Geometric Coefficient of Variation 32.5
|
185.65 liters
Geometric Coefficient of Variation 64.7
|
149.97 liters
Geometric Coefficient of Variation 53.5
|
153.23 liters
Geometric Coefficient of Variation 34.8
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞/Dose\[test\]) / (AUC0-∞/Dose\[reference\]) \* 100%.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose
|
39.85 percent availability
Geometric Coefficient of Variation 53.7
|
45.65 percent availability
Geometric Coefficient of Variation 47.0
|
47.37 percent availability
Geometric Coefficient of Variation 22.9
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞\[test\]) / (AUC0-∞\[reference\]) \* 100%.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Relative Bioavailability of Apremilast Test Formulations Relative to Reference
|
62.26 percent availability
Geometric Coefficient of Variation 53.7
|
71.33 percent availability
Geometric Coefficient of Variation 47.0
|
74.01 percent availability
Geometric Coefficient of Variation 22.9
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The pharmacokinetic (PK) population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Observed Maximum Plasma Concentration (Cmax) of Apremilast
|
405.38 ng/mL
Geometric Coefficient of Variation 30.2
|
368.45 ng/mL
Geometric Coefficient of Variation 37.2
|
298.96 ng/mL
Geometric Coefficient of Variation 34.1
|
325.20 ng/mL
Geometric Coefficient of Variation 35.1
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast
|
6635.78 ng*h/mL
Geometric Coefficient of Variation 35.9
|
5634.92 ng*h/mL
Geometric Coefficient of Variation 40.2
|
4780.60 ng*h/mL
Geometric Coefficient of Variation 39.3
|
5177.46 ng*h/mL
Geometric Coefficient of Variation 36.9
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast
|
6669.26 ng*h/mL
Geometric Coefficient of Variation 36.0
|
5700.66 ng*h/mL
Geometric Coefficient of Variation 40.1
|
4843.46 ng*h/mL
Geometric Coefficient of Variation 38.9
|
5259.40 ng*h/mL
Geometric Coefficient of Variation 35.9
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast
|
2.00 hours
Interval 1.0 to 3.0
|
4.00 hours
Interval 3.0 to 8.0
|
3.00 hours
Interval 2.0 to 6.0
|
4.00 hours
Interval 2.0 to 6.0
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Half-life of Apremilast in Terminal Phase (T1/2)
|
8.16 hours
Geometric Coefficient of Variation 26.3
|
8.98 hours
Geometric Coefficient of Variation 22.9
|
8.43 hours
Geometric Coefficient of Variation 28.9
|
8.75 hours
Geometric Coefficient of Variation 29.6
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Apparent Total Plasma Clearance (CL/F) of Apremilast
|
9.00 L/h
Geometric Coefficient of Variation 36.0
|
13.16 L/h
Geometric Coefficient of Variation 40.1
|
15.48 L/h
Geometric Coefficient of Variation 38.9
|
14.26 L/h
Geometric Coefficient of Variation 35.9
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Apparent Total Volume of Distribution (Vz/F) of Apremilast
|
105.88 liters
Geometric Coefficient of Variation 35.3
|
170.51 liters
Geometric Coefficient of Variation 34.0
|
188.24 liters
Geometric Coefficient of Variation 37.5
|
180.10 liters
Geometric Coefficient of Variation 48.3
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞/Dose\[test\]) / (AUC0-∞/Dose\[reference\]) \* 100%.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose
|
54.71 percent availability
Geometric Coefficient of Variation 26.0
|
46.48 percent availability
Geometric Coefficient of Variation 23.5
|
50.47 percent availability
Geometric Coefficient of Variation 13.2
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞\[test\]) / (AUC0-∞\[reference\]) \* 100%.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Relative Bioavailability of Apremilast Test Formulations Relative to Reference
|
85.48 percent availability
Geometric Coefficient of Variation 26.0
|
72.62 percent availability
Geometric Coefficient of Variation 23.5
|
78.86 percent availability
Geometric Coefficient of Variation 13.2
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Observed Maximum Plasma Concentration (Cmax) of Apremilast
|
378.59 ng/mL
Geometric Coefficient of Variation 31.6
|
344.61 ng/mL
Geometric Coefficient of Variation 28.7
|
334.51 ng/mL
Geometric Coefficient of Variation 33.6
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast
|
5493.38 ng*h/mL
Geometric Coefficient of Variation 33.7
|
4427.56 ng*h/mL
Geometric Coefficient of Variation 32.7
|
4310.62 ng*h/mL
Geometric Coefficient of Variation 35.0
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast
|
5518.28 ng*h/mL
Geometric Coefficient of Variation 33.8
|
4477.63 ng*h/mL
Geometric Coefficient of Variation 32.7
|
4359.49 ng*h/mL
Geometric Coefficient of Variation 35.0
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast
|
3.00 hours
Interval 2.0 to 5.03
|
4.00 hours
Interval 2.0 to 6.0
|
4.00 hours
Interval 2.0 to 6.0
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Half-life of Apremilast in Terminal Phase (T1/2)
|
6.45 hours
Geometric Coefficient of Variation 23.8
|
6.58 hours
Geometric Coefficient of Variation 29.2
|
7.05 hours
Geometric Coefficient of Variation 27.0
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Apparent Total Plasma Clearance (CL/F) of Apremilast
|
10.87 L/h
Geometric Coefficient of Variation 33.8
|
17.87 L/h
Geometric Coefficient of Variation 32.7
|
18.35 L/h
Geometric Coefficient of Variation 35.0
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Apparent Total Volume of Distribution (Vz/F) of Apremilast
|
101.23 liters
Geometric Coefficient of Variation 37.2
|
169.71 liters
Geometric Coefficient of Variation 34.0
|
186.69 liters
Geometric Coefficient of Variation 34.8
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞/Dose\[test\]) / (AUC0-∞/Dose\[reference\]) \* 100%.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose
|
45.64 percent availability
Geometric Coefficient of Variation 21.4
|
44.44 percent availability
Geometric Coefficient of Variation 21.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞\[test\]) / (AUC0-∞\[reference\]) \* 100%.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Relative Bioavailability of Apremilast Test Formulations Relative to Reference
|
81.14 percent availability
Geometric Coefficient of Variation 21.4
|
79.00 percent availability
Geometric Coefficient of Variation 21.1
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The pharmacokinetic (PK) population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=29 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
n=28 Participants
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Observed Maximum Plasma Concentration (Cmax) of Apremilast
|
438.90 ng/mL
Geometric Coefficient of Variation 29.1
|
480.59 ng/mL
Geometric Coefficient of Variation 24.9
|
481.10 ng/mL
Geometric Coefficient of Variation 29.3
|
316.43 ng/mL
Geometric Coefficient of Variation 48.5
|
450.23 ng/mL
Geometric Coefficient of Variation 32.5
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The pharmacokinetic (PK) population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=29 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
n=28 Participants
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measured Time Point (AUC0-t) of Apremilast
|
6976.02 ng*h/mL
Geometric Coefficient of Variation 32.3
|
5701.21 ng*h/mL
Geometric Coefficient of Variation 34.1
|
5811.24 ng*h/mL
Geometric Coefficient of Variation 29.0
|
4700.70 ng*h/mL
Geometric Coefficient of Variation 40.2
|
5324.80 ng*h/mL
Geometric Coefficient of Variation 36.5
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=29 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
n=28 Participants
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast
|
7000.35 ng*h/mL
Geometric Coefficient of Variation 32.2
|
5747.12 ng*h/mL
Geometric Coefficient of Variation 34.0
|
5875.19 ng*h/mL
Geometric Coefficient of Variation 28.6
|
4753.79 ng*h/mL
Geometric Coefficient of Variation 40.1
|
5374.83 ng*h/mL
Geometric Coefficient of Variation 36.8
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=29 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
n=28 Participants
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Time to Observed Maximum Plasma Concentration (Tmax) of Apremilast
|
3.00 hours
Interval 1.0 to 5.08
|
4.00 hours
Interval 2.0 to 6.0
|
4.00 hours
Interval 2.0 to 6.0
|
4.01 hours
Interval 2.0 to 14.0
|
3.52 hours
Interval 2.0 to 6.0
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=29 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
n=28 Participants
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Half-life of Apremilast in Terminal Phase (T1/2)
|
6.25 hours
Geometric Coefficient of Variation 24.8
|
7.40 hours
Geometric Coefficient of Variation 25.2
|
7.51 hours
Geometric Coefficient of Variation 34.9
|
7.09 hours
Geometric Coefficient of Variation 31.0
|
7.13 hours
Geometric Coefficient of Variation 32.5
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=29 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
n=28 Participants
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Apparent Total Plasma Clearance (CL/F) of Apremilast
|
8.57 L/h
Geometric Coefficient of Variation 32.2
|
13.92 L/h
Geometric Coefficient of Variation 34.0
|
13.62 L/h
Geometric Coefficient of Variation 28.6
|
16.83 L/h
Geometric Coefficient of Variation 40.1
|
14.88 L/h
Geometric Coefficient of Variation 36.8
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Concentrations of apremilast in plasma were measured using a validated liquid chromatography tandem mass spectrometry assay.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=29 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
n=28 Participants
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Apparent Total Volume of Distribution (Vz/F) of Apremilast
|
77.30 liters
Geometric Coefficient of Variation 36.0
|
148.66 liters
Geometric Coefficient of Variation 32.5
|
147.59 liters
Geometric Coefficient of Variation 41.5
|
172.16 liters
Geometric Coefficient of Variation 44.6
|
153.18 liters
Geometric Coefficient of Variation 36.1
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞/Dose\[test\]) / (AUC0-∞/Dose\[reference\]) \* 100%.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=27 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Relative Bioavailability of Apremilast Test Formulations Relative to Reference Corrected by Dose
|
46.18 percent availability
Geometric Coefficient of Variation 22.3
|
46.86 percent availability
Geometric Coefficient of Variation 27.7
|
38.65 percent availability
Geometric Coefficient of Variation 34.0
|
43.70 percent availability
Geometric Coefficient of Variation 26.9
|
—
|
PRIMARY outcome
Timeframe: IR reference formulation: predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the first dose; MR formulations: predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, and 72 hours postdose.Population: The PK population included all participants who received at least one dose of apremilast and had evaluable PK profiles.
Relative bioavailability of each test formulation compared to the reference formulation corrected by dose, calculated as: (AUC0-∞\[test\]) / (AUC0-∞\[reference\]) \* 100%.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=27 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Relative Bioavailability of Apremilast Test Formulations Relative to Reference
|
82.10 percent availability
Geometric Coefficient of Variation 22.3
|
83.31 percent availability
Geometric Coefficient of Variation 27.7
|
68.71 percent availability
Geometric Coefficient of Variation 34.0
|
77.68 percent availability
Geometric Coefficient of Variation 26.9
|
—
|
SECONDARY outcome
Timeframe: Adverse events were collected for 7 to 10 days after each treatment.Population: Participants who received at least one dose of apremilast.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug. A serious adverse event (SAE) is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 1: Number of Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
5 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Group 1: Number of Participants With Treatment-emergent Adverse Events
TEAEs related to study drug
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Group 1: Number of Participants With Treatment-emergent Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Group 1: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Group 1: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Group 1: Number of Participants With Treatment-emergent Adverse Events
Discontinuations due to adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Adverse events were collected for 7 to 10 days after each treatment.Population: Participants who received at least one dose of apremilast.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug. A serious adverse event (SAE) is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=16 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 2: Number of Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
4 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Group 2: Number of Participants With Treatment-emergent Adverse Events
TEAEs related to study drug
|
4 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
—
|
|
Group 2: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Group 2: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Group 2: Number of Participants With Treatment-emergent Adverse Events
Discontinuations due to adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Group 2: Number of Participants With Treatment-emergent Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Adverse events were collected for 7 to 10 days after each treatment.Population: Participants who received at least one dose of apremilast.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug. A serious adverse event (SAE) is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=18 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=18 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 3: Number of Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
5 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Group 3: Number of Participants With Treatment-emergent Adverse Events
TEAEs related to study drug
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Group 3: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Group 3: Number of Participants With Treatment-emergent Adverse Events
Discontinuations due to adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Group 3: Number of Participants With Treatment-emergent Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Group 3: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Adverse events were collected for 7 to 10 days after each treatment.Population: Participants who received at least one dose of apremilast.
An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. A treatment-emergent AE (TEAE) was defined as any AE that occurred after dosing of the study drug. A serious adverse event (SAE) is any AE occurring at any dose that: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Constituted an important medical event.
Outcome measures
| Measure |
Group 1: Apremilast Immediate Release
n=29 Participants
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=29 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=28 Participants
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=28 Participants
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 4: Apremilast Modified Release 14
n=28 Participants
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
|---|---|---|---|---|---|
|
Group 4: Number of Participants With Treatment-emergent Adverse Events
Any treatment-emergent adverse event (TEAE)
|
13 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
9 Participants
|
|
Group 4: Number of Participants With Treatment-emergent Adverse Events
TEAE related to study drug
|
9 Participants
|
7 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
|
Group 4: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Group 4: Number of Participants With Treatment-emergent Adverse Events
Serious adverse events related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Group 4: Number of Participants With Treatment-emergent Adverse Events
Discontinuation due to adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Group 4: Number of Participants With Treatment-emergent Adverse Events
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: Apremilast Immediate Release
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 1: Apremilast Modified Release 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 1: Apremilast Modified Release 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 1: Apremilast Modified Release 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 1 Total
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: Apremilast Immediate Release
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: Apremilast Modified Release 4
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2: Apremilast Modified Release 5
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 2: Apremilast Modified Release 6
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2 Total
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 3: Apremilast Immediate Release
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3: Apremilast Modified Release 8
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3: Apremilast Modified Release 9
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3 Total
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 4: Apremilast Immediate Release
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 4: Apremilast Modified Release 11
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4: Apremilast Modified Release 12
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 4: Apremilast Modified Release 13
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 4: Apremilast Modified Release 14
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 4 Total
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Overall Total
Serious events: 0 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Apremilast Immediate Release
n=16 participants at risk
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 1: Apremilast Modified Release 1
n=16 participants at risk
Participants received a single oral dose 75 mg apremilast tablet prototype MR 1.
|
Group 1: Apremilast Modified Release 2
n=16 participants at risk
Participants received a single oral dose 75 mg apremilast tablet prototype MR 2.
|
Group 1: Apremilast Modified Release 3
n=16 participants at risk
Participants received a single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 1 Total
n=16 participants at risk
Participants received the following 4 treatments, given in 4 possible sequences (ADBC, BACD, CBDA, and DCAB) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) B) A single oral dose 75 mg apremilast tablet prototype MR 1 C) A single oral dose 75 mg apremilast tablet prototype MR 2 D) A single oral dose 75 mg apremilast capsule prototype MR 3.
|
Group 2: Apremilast Immediate Release
n=16 participants at risk
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 2: Apremilast Modified Release 4
n=16 participants at risk
Participants received a single oral dose 75 mg apremilast capsule prototype MR 4.
|
Group 2: Apremilast Modified Release 5
n=16 participants at risk
Participants received a single oral dose 75 mg apremilast capsule prototype MR 5.
|
Group 2: Apremilast Modified Release 6
n=16 participants at risk
Participants received a single oral dose 75 mg apremilast capsule prototype MR 6.
|
Group 2 Total
n=16 participants at risk
Participants received the following 4 treatments, given in 4 possible sequences (AGEF, EAFG, FEGA, and GFAE) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) E) A single oral dose 75 mg apremilast capsule prototype MR 4 F) A single oral dose 75 mg apremilast capsule prototype MR 5 G) A single oral dose 75 mg apremilast capsule prototype MR 6
|
Group 3: Apremilast Immediate Release
n=18 participants at risk
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 3: Apremilast Modified Release 8
n=18 participants at risk
Participants received a single oral dose 80 mg apremilast capsule prototype MR 8.
|
Group 3: Apremilast Modified Release 9
n=18 participants at risk
Participants received a single oral dose 80 mg apremilast capsule prototype MR 9.
|
Group 3 Total
n=18 participants at risk
Participants received the following 3 treatments, given in 6 possible sequences (AIJ, IJA, JAI, AJI, IAJ, or JIA) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) I) A single oral dose 80 mg apremilast capsule prototype MR 8 J) A single oral dose 80 mg apremilast capsule prototype MR 9
|
Group 4: Apremilast Immediate Release
n=29 participants at risk
Participants received two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation).
|
Group 4: Apremilast Modified Release 11
n=29 participants at risk
Participants received a single oral dose 80 mg apremilast capsule prototype MR 11.
|
Group 4: Apremilast Modified Release 12
n=28 participants at risk
Participants received a single oral dose 80 mg apremilast capsule prototype MR 12.
|
Group 4: Apremilast Modified Release 13
n=28 participants at risk
Participants received a single oral dose 80 mg apremilast capsule prototype MR 13.
|
Group 4: Apremilast Modified Release 14
n=28 participants at risk
Participants received a single oral dose 80 mg apremilast capsule prototype MR 14.
|
Group 4 Total
n=30 participants at risk
Participants received the following 5 treatments, given in 10 possible sequences (ALOMN, LMANO, MNLOA, NOMAL, OANLM, NMOLA, ONAML, AOLNM, LAMON, or MLNAO) with 7 to 10 days between each treatment:
A) Two oral doses of 30 mg apremilast immediate release tablets 12 hours apart (reference formulation) L) A single oral dose 80 mg apremilast capsule prototype MR 11 M) A single oral dose 80 mg apremilast capsule prototype MR 12 N) A single oral dose 80 mg apremilast capsule prototype MR 13 O) A single oral dose 80 mg apremilast capsule prototype MR 14
|
Overall Total
n=80 participants at risk
All participants who received any dose of apremilast during the study.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.3%
1/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
2.5%
2/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
7.1%
2/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
16.7%
5/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
8.8%
7/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.7%
2/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
2.5%
2/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Gastrointestinal disorders
CHANGE OF BOWEL HABIT
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
12.5%
2/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
12.5%
2/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
18.8%
3/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
10.0%
3/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
7.5%
6/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Gastrointestinal disorders
NAUSEA
|
12.5%
2/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
12.5%
2/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
18.8%
3/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
18.8%
3/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
11.1%
2/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.9%
2/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
13.3%
4/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
13.8%
11/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
12.5%
2/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.3%
1/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.8%
3/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
10.0%
3/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.8%
3/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.3%
1/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.8%
3/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.3%
1/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
2.5%
2/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.6%
1/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.7%
2/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.8%
3/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Injury, poisoning and procedural complications
PROCEDURAL SITE REACTION
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
11.1%
2/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
16.7%
3/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.3%
1/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
5/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
7.1%
2/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
7.1%
2/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
14.3%
4/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
16.7%
5/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
7.5%
6/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Nervous system disorders
HEADACHE
|
18.8%
3/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
12.5%
2/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
25.0%
4/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
18.8%
3/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
12.5%
2/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
31.2%
5/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
27.6%
8/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
13.8%
4/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
14.3%
4/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
10.7%
3/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
14.3%
4/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
43.3%
13/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
27.5%
22/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Nervous system disorders
PRESYNCOPE
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
11.1%
2/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
11.1%
2/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.4%
1/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.3%
1/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
3.8%
3/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
5.6%
1/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Respiratory, thoracic and mediastinal disorders
DRY THROAT
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
6.2%
1/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/16 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/18 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/29 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/28 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
0.00%
0/30 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
1.2%
1/80 • Adverse events were collected for 7 to 10 days after each treatment.
Adverse events are reported for all participants who received at least one dose of apremilast.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER