Trial Outcomes & Findings for The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics (NCT NCT02170376)
NCT ID: NCT02170376
Last Updated: 2016-09-20
Results Overview
Cmax - Maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administration
Results posted on
2016-09-20
Participant Flow
Participant milestones
| Measure |
Group 1: Placebo Then Entacapone/Levodopa
Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12
Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 2: BIA 25 mg Then Placebo/Levodopa/Carbidopa
25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 3: BIA 50 mg Then Placebo/Levodopa/Carbidopa
50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 4: BIA 75 mg Then Placebo/Levodopa/Carbidopa
75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 5: Placebo Then Levodopa/Carbidopa
placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
16
|
|
Overall Study
Pharmacokinetic Population
|
16
|
15
|
16
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
16
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics
Baseline characteristics by cohort
| Measure |
Group 1
n=16 Participants
Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12
Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 2
n=16 Participants
25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 3
n=16 Participants
50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 4
n=16 Participants
75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 5
n=16 Participants
placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
80 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
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
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administrationCmax - Maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo: PLC, placebo
|
OPC 25 mg
n=15 Participants
OPC: BIA 9-1067 25 mg
|
OPC 50 mg
n=16 Participants
OPC: BIA 9-1067 50 mg
|
OPC 75 mg
n=16 Participants
OPC: BIA 9-1067 25 mg and 50 mg
|
ENT 200 mg
n=16 Participants
Entacapone (ENT), over-encapsulated tablet 200 mg
|
|---|---|---|---|---|---|
|
Cmax - Maximum Plasma Concentration of Levodopa
Post First Dose
|
1047 ng/mL
Standard Deviation 340
|
1203 ng/mL
Standard Deviation 453
|
1030 ng/mL
Standard Deviation 400
|
1057 ng/mL
Standard Deviation 335
|
876 ng/mL
Standard Deviation 328
|
|
Cmax - Maximum Plasma Concentration of Levodopa
Post Second Dose
|
1550 ng/mL
Standard Deviation 542
|
1619 ng/mL
Standard Deviation 762
|
1974 ng/mL
Standard Deviation 847
|
2113 ng/mL
Standard Deviation 868
|
1437 ng/mL
Standard Deviation 569
|
|
Cmax - Maximum Plasma Concentration of Levodopa
Post Third Dose
|
1268 ng/mL
Standard Deviation 532
|
1393 ng/mL
Standard Deviation 627
|
1346 ng/mL
Standard Deviation 337
|
1658 ng/mL
Standard Deviation 435
|
1303 ng/mL
Standard Deviation 518
|
PRIMARY outcome
Timeframe: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administrationTmax - Time to Reach maximum plasma concentration of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo: PLC, placebo
|
OPC 25 mg
n=15 Participants
OPC: BIA 9-1067 25 mg
|
OPC 50 mg
n=16 Participants
OPC: BIA 9-1067 50 mg
|
OPC 75 mg
n=16 Participants
OPC: BIA 9-1067 25 mg and 50 mg
|
ENT 200 mg
n=16 Participants
Entacapone (ENT), over-encapsulated tablet 200 mg
|
|---|---|---|---|---|---|
|
Tmax - Time of Occurrence of Maximum Plasma Concentration
Post First Dose
|
1.31 hours
Standard Deviation 0.854
|
1.13 hours
Standard Deviation 0.790
|
1.34 hours
Standard Deviation 1.01
|
1.28 hours
Standard Deviation 0.515
|
1.13 hours
Standard Deviation 0.695
|
|
Tmax - Time of Occurrence of Maximum Plasma Concentration
Post Second Dose
|
0.875 hours
Standard Deviation 0.465
|
1.20 hours
Standard Deviation 0.862
|
1.06 hours
Standard Deviation 0.892
|
1.19 hours
Standard Deviation 0.854
|
0.906 hours
Standard Deviation 0.491
|
|
Tmax - Time of Occurrence of Maximum Plasma Concentration
Post Third Dose
|
1.69 hours
Standard Deviation 0.964
|
1.33 hours
Standard Deviation 0.699
|
1.34 hours
Standard Deviation 0.65
|
1.31 hours
Standard Deviation 0.854
|
1.59 hours
Standard Deviation 0.861
|
PRIMARY outcome
Timeframe: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administrationAUC0-â of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo: PLC, placebo
|
OPC 25 mg
n=15 Participants
OPC: BIA 9-1067 25 mg
|
OPC 50 mg
n=16 Participants
OPC: BIA 9-1067 50 mg
|
OPC 75 mg
n=16 Participants
OPC: BIA 9-1067 25 mg and 50 mg
|
ENT 200 mg
n=16 Participants
Entacapone (ENT), over-encapsulated tablet 200 mg
|
|---|---|---|---|---|---|
|
AUC0-â - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase
Post First Dose
|
2305 ng.h/mL
Standard Deviation 391
|
3732 ng.h/mL
Standard Deviation 1418
|
3363 ng.h/mL
Standard Deviation 1042
|
3998 ng.h/mL
Standard Deviation 1275
|
2752 ng.h/mL
Standard Deviation 540
|
|
AUC0-â - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase
Post Second Dose
|
3070 ng.h/mL
Standard Deviation 396
|
4967 ng.h/mL
Standard Deviation 2003
|
5727 ng.h/mL
Standard Deviation 1495
|
6213 ng.h/mL
Standard Deviation 1440
|
4367 ng.h/mL
Standard Deviation 1463
|
|
AUC0-â - Area Under the Concentration-time Curve From Time Zero up to Infinity With Extrapolation of the Terminal Phase
Post Third Dose
|
3299 ng.h/mL
Standard Deviation 433
|
5614 ng.h/mL
Standard Deviation 2467
|
5912 ng.h/mL
Standard Deviation 1478
|
7177 ng.h/mL
Standard Deviation 1835
|
4707 ng.h/mL
Standard Deviation 363
|
PRIMARY outcome
Timeframe: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administrationAUC0-t - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo: PLC, placebo
|
OPC 25 mg
n=15 Participants
OPC: BIA 9-1067 25 mg
|
OPC 50 mg
n=16 Participants
OPC: BIA 9-1067 50 mg
|
OPC 75 mg
n=16 Participants
OPC: BIA 9-1067 25 mg and 50 mg
|
ENT 200 mg
n=16 Participants
Entacapone (ENT), over-encapsulated tablet 200 mg
|
|---|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.
Post First Dose
|
1985 ng.h/mL
Standard Deviation 346
|
2665 ng.h/mL
Standard Deviation 867
|
2383 ng.h/mL
Standard Deviation 699
|
2829 ng.h/mL
Standard Deviation 794
|
2041 ng.h/mL
Standard Deviation 671
|
|
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.
Post Second Dose
|
2774 ng.h/mL
Standard Deviation 353
|
3678 ng.h/mL
Standard Deviation 1455
|
4151 ng.h/mL
Standard Deviation 1070
|
4597 ng.h/mL
Standard Deviation 1041
|
3445 ng.h/mL
Standard Deviation 1128
|
|
AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Time (t) Corresponding to the Last Quantifiable Concentration.
Post Third Dose
|
3123 ng.h/mL
Standard Deviation 447
|
5391 ng.h/mL
Standard Deviation 2444
|
5685 ng.h/mL
Standard Deviation 1466
|
6928 ng.h/mL
Standard Deviation 1797
|
4366 ng.h/mL
Standard Deviation 1426
|
PRIMARY outcome
Timeframe: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administrationAUC0-5 - of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo: PLC, placebo
|
OPC 25 mg
n=15 Participants
OPC: BIA 9-1067 25 mg
|
OPC 50 mg
n=16 Participants
OPC: BIA 9-1067 50 mg
|
OPC 75 mg
n=16 Participants
OPC: BIA 9-1067 25 mg and 50 mg
|
ENT 200 mg
n=16 Participants
Entacapone (ENT), over-encapsulated tablet 200 mg
|
|---|---|---|---|---|---|
|
AUC0-5 - AUC Over 5 Hours
Post First Dose
|
1985 ng.h/mL
Standard Deviation 346
|
2665 ng.h/mL
Standard Deviation 867
|
2383 ng.h/mL
Standard Deviation 699
|
2829 ng.h/mL
Standard Deviation 794
|
2042 ng.h/mL
Standard Deviation 669
|
|
AUC0-5 - AUC Over 5 Hours
Post Second Dose
|
2774 ng.h/mL
Standard Deviation 353
|
3678 ng.h/mL
Standard Deviation 1455
|
4151 ng.h/mL
Standard Deviation 1070
|
4597 ng.h/mL
Standard Deviation 1041
|
3446 ng.h/mL
Standard Deviation 1125
|
|
AUC0-5 - AUC Over 5 Hours
Post Third Dose
|
2719 ng.h/mL
Standard Deviation 492
|
3802 ng.h/mL
Standard Deviation 1549
|
3940 ng.h/mL
Standard Deviation 1022
|
4882 ng.h/mL
Standard Deviation 1246
|
3468 ng.h/mL
Standard Deviation 1108
|
PRIMARY outcome
Timeframe: pre-first dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0 and 5.0 h post-first and -second levodopa/carbidopa administration, and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 8.0 and 14.0 h post-third levodopa/carbidopa administrationt1/2 - Terminal plasma half-life of levodopa (mean pharmacokinetic parameter) following first oral administration of 100/25 mg levodopa/carbidopa on Day 12 with 25, 50 and 75 mg OPC or placebo and 200 mg Entacapone.
Outcome measures
| Measure |
Placebo
n=16 Participants
Placebo: PLC, placebo
|
OPC 25 mg
n=15 Participants
OPC: BIA 9-1067 25 mg
|
OPC 50 mg
n=16 Participants
OPC: BIA 9-1067 50 mg
|
OPC 75 mg
n=16 Participants
OPC: BIA 9-1067 25 mg and 50 mg
|
ENT 200 mg
n=16 Participants
Entacapone (ENT), over-encapsulated tablet 200 mg
|
|---|---|---|---|---|---|
|
t1/2 - Terminal Plasma Half-life
Post First Dose
|
1.46 Hours
Standard Deviation 0.406
|
2.47 Hours
Standard Deviation 0.830
|
2.47 Hours
Standard Deviation 0.098
|
2.39 Hours
Standard Deviation 0.556
|
2.11 Hours
Standard Deviation 0.626
|
|
t1/2 - Terminal Plasma Half-life
Post Second Dose
|
1.41 Hours
Standard Deviation 0.136
|
2.23 Hours
Standard Deviation 0.385
|
2.46 Hours
Standard Deviation 0.312
|
2.23 Hours
Standard Deviation 0.513
|
2.09 Hours
Standard Deviation 0.486
|
|
t1/2 - Terminal Plasma Half-life
Post Third Dose
|
1.74 Hours
Standard Deviation 0.349
|
2.56 Hours
Standard Deviation 0.440
|
2.75 Hours
Standard Deviation 0.513
|
2.70 Hours
Standard Deviation 0.462
|
2.20 Hours
Standard Deviation 0.632
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 5
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=16 participants at risk
Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12
Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 2
n=16 participants at risk
25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 3
n=16 participants at risk
50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 4
n=16 participants at risk
75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
BIA 9-1067: BIA 9-1067 25 mg and 50 mg
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
Group 5
n=16 participants at risk
placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12
Placebo: PLC, placebo
Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
|
Cardiac disorders
Palpitations
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.2%
1/16
|
6.2%
1/16
|
6.2%
1/16
|
6.2%
1/16
|
6.2%
1/16
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16
|
0.00%
0/16
|
12.5%
2/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16
|
18.8%
3/16
|
50.0%
8/16
|
50.0%
8/16
|
25.0%
4/16
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
|
18.8%
3/16
|
12.5%
2/16
|
18.8%
3/16
|
6.2%
1/16
|
|
Infections and infestations
Rhinitis
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
6.2%
1/16
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16
|
6.2%
1/16
|
6.2%
1/16
|
0.00%
0/16
|
12.5%
2/16
|
|
Nervous system disorders
Headache
|
31.2%
5/16
|
12.5%
2/16
|
12.5%
2/16
|
6.2%
1/16
|
12.5%
2/16
|
|
Nervous system disorders
Somnolence
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
12.5%
2/16
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Pityriasis
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
|
Vascular disorders
Hot Flush
|
0.00%
0/16
|
0.00%
0/16
|
18.8%
3/16
|
12.5%
2/16
|
6.2%
1/16
|
|
Vascular disorders
Varicophlebitis
|
0.00%
0/16
|
0.00%
0/16
|
6.2%
1/16
|
0.00%
0/16
|
0.00%
0/16
|
Additional Information
Head of Clinical Research
Bial - Portela & CÂȘ, S.A.
Phone: +351 229 866 100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER