Trial Outcomes & Findings for STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS (NCT NCT05093205)
NCT ID: NCT05093205
Last Updated: 2024-08-19
Results Overview
Atorvastatin was given on Day 1 in Periods 1, 4 and 7 of Part A and blood samples were collected for atorvastatin pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.
Results posted on
2024-08-19
Participant Flow
Participant milestones
| Measure |
Atorvastatin 20 mg (Part A Period 1)
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
Midazolam 5 mg (Part A Period 2)
Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.
|
PF-06882961 Titration up to 120 mg BID (Part A Period 3)
Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 3.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
0.15 mg LE & 0.03 mg EE (Part B Period 1)
Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
|
PF-06882961 Titration up to 120 mg BID (Part B Period 2)
Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B.
|
PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)
Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.
|
PF-06882961 Titration up to 200 mg BID (Part B Period 4)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 4 in Part B.
|
PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)
Participants received PF-06882961 200 mg BID + oral contraceptive SD on Day 1 and PF-06882961 200 mg BID on Days 2-5 of Period 5 in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Period 1 - Treatment
STARTED
|
18
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 1 - Treatment
COMPLETED
|
18
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 1 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 1 - Follow-Up
STARTED
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 1 - Follow-Up
COMPLETED
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 1 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 2 - Treatment
STARTED
|
0
|
18
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 2 - Treatment
COMPLETED
|
0
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 2 - Treatment
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 2 - Follow-Up
STARTED
|
0
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 2 - Follow-Up
COMPLETED
|
0
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 2 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Treatment
STARTED
|
0
|
0
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Treatment
COMPLETED
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Treatment
NOT COMPLETED
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Follow-Up
STARTED
|
0
|
0
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Follow-Up
COMPLETED
|
0
|
0
|
15
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 4 - Treatment
STARTED
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 4 - Treatment
COMPLETED
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 4 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 4 - Follow-Up
STARTED
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 4 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 4 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 5 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 5 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 5 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 5 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 5 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 5 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 6 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 6 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 6 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 6 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 6 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 6 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 7 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 7 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 7 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 7 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 7 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 7 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 8 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 8 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 8 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 8 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 8 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 8 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B Period 1 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
17
|
0
|
0
|
0
|
0
|
|
Part B Period 1 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
0
|
0
|
0
|
0
|
|
Part B Period 1 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part B Period 1 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
0
|
0
|
0
|
0
|
|
Part B Period 1 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
0
|
0
|
0
|
0
|
|
Part B Period 1 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B Period 2 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
0
|
0
|
0
|
|
Part B Period 2 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
0
|
|
Part B Period 2 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part B Period 2 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
15
|
0
|
0
|
0
|
|
Part B Period 2 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
0
|
|
Part B Period 2 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part B Period 3 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
14
|
0
|
0
|
|
Part B Period 3 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
0
|
0
|
|
Part B Period 3 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part B Period 3 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
|
Part B Period 3 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
0
|
0
|
|
Part B Period 3 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part B Period 4 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
12
|
0
|
|
Part B Period 4 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
|
Part B Period 4 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Part B Period 4 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
11
|
0
|
|
Part B Period 4 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
0
|
|
Part B Period 4 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part B Period 5 - Treatment
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Part B Period 5 - Treatment
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Part B Period 5 - Treatment
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B Period 5 - Follow-Up
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Part B Period 5 - Follow-Up
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
9
|
|
Part B Period 5 - Follow-Up
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Atorvastatin 20 mg (Part A Period 1)
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
Midazolam 5 mg (Part A Period 2)
Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.
|
PF-06882961 Titration up to 120 mg BID (Part A Period 3)
Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 3.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
0.15 mg LE & 0.03 mg EE (Part B Period 1)
Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
|
PF-06882961 Titration up to 120 mg BID (Part B Period 2)
Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B.
|
PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)
Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.
|
PF-06882961 Titration up to 200 mg BID (Part B Period 4)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 4 in Part B.
|
PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)
Participants received PF-06882961 200 mg BID + oral contraceptive SD on Day 1 and PF-06882961 200 mg BID on Days 2-5 of Period 5 in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Period 2 - Treatment
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Treatment
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Treatment
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 3 - Treatment
Adverse Event
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 6 - Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A Period 8 - Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Part B Period 1 - Treatment
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Part B Period 2 - Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part B Period 2 - Follow-Up
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part B Period 3 - Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part B Period 3 - Follow-Up
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Part B Period 4 - Treatment
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Part B Period 4 - Treatment
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Part B Period 4 - Follow-Up
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
Baseline characteristics by cohort
| Measure |
All Participants in Part A
n=18 Participants
Participants underwent Period 1 to 8 and received study interventions as follows: Period 1: atorvastatin 20mg single dose (SD) on Day 1; Period 2: midazolam 5mg SD on Day 1; Period 3: PF-06882961 10mg twice daily (BID) on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 4: PF-06882961 120mg BID+atorvastatin SD on Day 1, PF-06882961 120mg on Days 2-3; Period 5: PF-06882961 120 mg BID+ midazolam SD on Day 1; Period 6: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 7: PF-06882961 200 mg BID+atorvastatin SD on Day 1, PF-06882961 200 mg BID on Days 2-3; Part 8: PF-06882961 200 mg BID+ midazolam SD on Day 1.
|
All Participants in Part B
n=17 Participants
Participants underwent Period 1 to 5 and received study interventions as follows: Period 1: oral contraceptive (OC) SD on Day 1; Period 2:PF-06882961 10mg BID on Days 1-4, 20mg BID on Days 5-8, 40mg BID on Days 9-12, 60mg BID on Days 13-16, 80mg BID on Days 17-20, 100mg BID on Days 21-24, and 120mg BID on Days 25-31; Period 3: PF-06882961 120mg BID+OC SD on Day 1, PF-06882961 120mg on Days 2-5; Period 4: PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, 200 mg BID on Days 13-19; Period 5: PF-06882961 200 mg BID+OC SD on Day 1, PF-06882961 200 mg BID on Days 2-5.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Mean (SD)
|
41.2 Years
STANDARD_DEVIATION 11.63 • n=5 Participants
|
54.5 Years
STANDARD_DEVIATION 4.16 • n=7 Participants
|
47.7 Years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
|
Age, Customized
<18 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18-25 Years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
26-35 Years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
36-45 Years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
>45 Years
|
8 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For Part A Periods 1, 4, and 7: At 0 (prior to atorvastatin dose), 0.5, 1, 1.5, 2, 4, 6, 9, 12, 24, 36, 48, 72 hours (only Periods 1 & 4) post atorvastatin dose on Day 1 of each period.Population: Only participants with evaluable results for the pharmacokinetic (PK) parameter were included in the analysis.
Atorvastatin was given on Day 1 in Periods 1, 4 and 7 of Part A and blood samples were collected for atorvastatin pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=16 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=11 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=3 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7
|
32.27 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 41
|
46.94 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 72
|
54.43 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: For Part A Periods 2, 5, and 8: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours (only for Periods 2 & 5) post midazolam dose on Day 1 of each period.Population: Only participants with evaluable results for the PK parameter were included in the analysis.
Midazolam was given on Day 1 in Periods 2, 5 and 8 of Part A and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=18 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=13 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=5 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) AUCinf of Midazolam in Periods 2, 5, and 8
|
70.53 ng*hr/mL
Geometric Coefficient of Variation 32
|
58.81 ng*hr/mL
Geometric Coefficient of Variation 40
|
49.78 ng*hr/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: For Part B Periods 1, 3, 5: At 0 (prior to levonorgestrel dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post levonorgestrel dose on Day 1 of each period.Population: Only participants with evaluable results for the PK parameter were included in the analysis.
Levonorgestrel was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for levonorgestrel PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=15 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=12 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=8 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) AUCinf of Levonorgestrel in Periods 1, 3 and 5
|
48800 picogram*hour/milliliter (pg*hr/mL)
Geometric Coefficient of Variation 42
|
62330 picogram*hour/milliliter (pg*hr/mL)
Geometric Coefficient of Variation 61
|
66490 picogram*hour/milliliter (pg*hr/mL)
Geometric Coefficient of Variation 57
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: For Part B Periods 1, 3, 5: At 0 (prior to EE dose), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post EE dose on Day 1 in Periods 1, 3, 5 of each period.Population: Only participants with evaluable results for the PK parameter were included in the analysis.
Ethinyl estradiol (EE) was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for ethinyl estradiol PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=16 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=12 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=9 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) AUCinf of Ethinyl Estradiol in Periods 1, 3 and 5
|
772.1 pg*hr/mL
Geometric Coefficient of Variation 41
|
723.5 pg*hr/mL
Geometric Coefficient of Variation 24
|
604.4 pg*hr/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to follow-up telephone contact (Days 90-97) in Part A of the study.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=18 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=18 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=17 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=13 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=13 Participants
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
n=13 Participants
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=5 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
n=6 Participants
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Participants with adverse events
|
2 Participants
|
3 Participants
|
13 Participants
|
5 Participants
|
4 Participants
|
12 Participants
|
5 Participants
|
2 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Participants with serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Participants with severe adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Participants discontinued from study due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Participants discontinued study drug due to AE and continue study
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
1 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Adverse Events (TEAE) During Part A of the Study
Participants with dose reduced or temporary discontinuation due to AE
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to follow-up telephone contact (Days 94-101) in Part B of the study.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event was defined as any untoward medical occurrence that,at any dose:resulted in death;was life-threatening;required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent disability/incapacity; was a congenital anomaly/birth defect;or other serious situations such as important medical events. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=17 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=16 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=14 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=12 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=9 Participants
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) Number of Participants With TEAE During Part B of the Study
Participants with adverse events
|
5 Participants
|
15 Participants
|
7 Participants
|
12 Participants
|
7 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With TEAE During Part B of the Study
Participants with serious adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With TEAE During Part B of the Study
Participants with severe adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With TEAE During Part B of the Study
Participants discontinued from study due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With TEAE During Part B of the Study
Participants discontinued study drug due to AE and continue study
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With TEAE During Part B of the Study
Participants with dose reduced or temporary discontinuation due to AE
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=18 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=18 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=17 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=13 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=13 Participants
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
n=13 Participants
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=5 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
n=6 Participants
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) Number of Participants With Clinical Laboratory Abnormalities During Part A of the Study (Without Regard to Baseline Abnormality)
|
0 Participants
|
15 Participants
|
16 Participants
|
2 Participants
|
5 Participants
|
12 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=17 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=16 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=4 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=12 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=9 Participants
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) Number of Participants With Clinical Laboratory Abnormalities During Part B of the Study (Without Regard to Baseline Abnormality)
|
17 Participants
|
16 Participants
|
2 Participants
|
12 Participants
|
9 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Supine blood pressure (mm Hg) and pulse rate (beats per minute) were measured. Supine BP was measured with the participant's arm supported at heart level and recorded to the nearest mmHg after approximately 5 minutes of rest.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=18 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=18 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=17 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=13 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=13 Participants
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
n=13 Participants
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=5 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
n=6 Participants
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Supine systolic blood pressure (SBP) value <90 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Supine SBP change >=30 mm Hg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Supine SBP change >=30 mm Hg decrease
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Supine diastolic blood pressure (DBP) value <50 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Supine DBP >= 20 mm Hg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Supine DBP >= 20 mm Hg decrease
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Pulse rate value <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Vital Signs Abnormalities During Part A of the Study
Pulse rate value >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Supine blood pressure (mm Hg) and pulse rate (bpm) were measured. Supine BP was measured with the participant's arm supported at heart level and recorded to the nearest mmHg after approximately 5 minutes of rest.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=17 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=16 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=2 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=12 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=9 Participants
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Supine SBP value <90 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Supine SBP change >=30 mm Hg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Supine SBP change >=30 mm Hg decrease
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Supine DBP value <50 mm Hg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Supine DBP >= 20 mm Hg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Supine DBP >= 20 mm Hg decrease
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Pulse rate value <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Vital Signs Abnormalities During Part B of the Study
Pulse rate value >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Percentage of change from Baseline 1: from the last pre-dose measurement in Part A Period 1 (ie, Baseline 1) to Day 2 of Part A Period 8; percentage of Change from the last predose measurement in Part A Period 3 (ie, Baseline 2) to Day 2 of Period 8.Population: All participants who were randomly assigned to study intervention and had at least 1 dose of study intervention, and with evaluable body weight measurement were included in the analysis.
Percentage of changes from Baseline in body weight of the participants were measured.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=6 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) Percentage of Change From Baseline in Body Weight
Baseline 2 - Period 8 Day 2 / PF-06882961 200 mg BID + Midazolam 5 mg
|
-9.30 percentage
Standard Deviation 4.159
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Percentage of Change From Baseline in Body Weight
Baseline 1 - Period 8 Day 2 / PF-06882961 200 mg BID + Midazolam 5 mg
|
-9.04 percentage
Standard Deviation 3.539
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Percentage of Change from Baseline 1:from the last pre-dose measurement in Part B Period 1 (ie, Baseline 1) to Day 2 of Part B Period 8;percentage of Change from the last predose measurement in Part B Period 2 (ie, Baseline 2) to Day 6 of Part B Period 5.Population: All participants who were randomly assigned to study intervention and had at least 1 dose of study intervention, and with evaluable body weight measurement were included in the analysis.
Percentage of changes from Baseline in body weight of the participants were measured.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=17 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) Percentage of Change From Baseline in Body Weight
Baseline 1 - Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE
|
-8.77 percentage
Standard Deviation 2.190
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Percentage of Change From Baseline in Body Weight
Baseline 2 - Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE
|
-5.40 percentage
Standard Deviation 1.503
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline up to follow-up visit (Days 69-72) in Part A of the study.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measured PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=18 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=18 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=17 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=13 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=13 Participants
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
n=13 Participants
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=5 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
n=6 Participants
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
PR interval value >=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
PR interval %change >=25/50% msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
QRS interval value >= 140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
QRS interval %change >=50% msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
QTcF 450 msec < value <=480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
QTcF 480 msec < value <=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
QTcF value >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
QTcF 30 msec < change <=60 msec
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
(Part A) Number of Participants With Treatment Emergent Electrocardiograms (ECG) Abnormalities During Part A of the Study
QTcF change >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to follow-up visit (Days 72-75) in Part B of the study.Population: All participants randomly assigned to study intervention and who had at least 1 dose of study intervention.
Standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate and measured PR, QT, and QT interval corrected for heart rate (QTc) and QRS complex.
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=17 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=16 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=2 Participants
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=12 Participants
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=9 Participants
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
QTcF 450 msec < value <=480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
QTcF 480 msec < value <=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
PR interval value >=300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
PR interval %change >=25/50% msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
QRS interval value >= 140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
QRS interval %change >=50% msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
QTcF value >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
QTcF 30 msec < change <=60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Treatment Emergent ECG Abnormalities During Part B of the Study
QTcF change >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.
The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=18 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 1 Day -1 / Atorvastatin 20 mg
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 1 Day -1 / Atorvastatin 20 mg Past 12 Months
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Follow Up (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.
The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=17 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE (Past 12 months)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the C-SSRS
Follow Up (Since Last Visit)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D5 (P3D1), D12 (P3D8), D19 (P3D15), D27 (P3D23), D36 (P4D1), D40 (P6D1), D48 (P6D9), D58 (P6D19), D62 (P8D1), and at follow-up visit (Days 69-72) of Part A.Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.
The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 \[not at all\] to 3 \[nearly every day\]. Higher score=greater severity).
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=18 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 23 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Little Interest/Pleasure in Things · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Down Depressed or Hopeless · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Falling or Staying Asleep · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Tired or Little Energy · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Poor Appetite or Overeating · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Poor Appetite or Overeating · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Poor Appetite or Overeating · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Bad About Yourself · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Concentrating on Things · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Thoughts You Be Better Off Dead · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 4 Day 1 / PF-06882961 120 mg BID + Atorvastatin 20 mg / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Not At All
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Not At All
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Not At All
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 6 Day 19 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Little Interest/Pleasure in Things · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Little Interest/Pleasure in Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Down Depressed or Hopeless · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Down Depressed or Hopeless · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Falling or Staying Asleep · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Falling or Staying Asleep · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Tired or Little Energy · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Poor Appetite or Overeating · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Bad About Yourself · Not At All
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Concentrating on Things · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Concentrating on Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Moving Slowly or Fidgety/Restless · Not At All
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Moving Slowly or Fidgety/Restless · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Thoughts You Be Better Off Dead · Not At All
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 8 Day 1 / PF-06882961 200 mg BID + Midazolam 5 mg / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Follow Up · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Little Interest/Pleasure in Things · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Down Depressed or Hopeless · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Trouble Falling or Staying Asleep · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Tired or Little Energy · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Poor Appetite or Overeating · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Bad About Yourself · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Trouble Concentrating on Things · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Thoughts You Be Better Off Dead · Not At All
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 1 Day -1 / Atorvastatin 20 mg / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part A) Number of Participants With Categorical Scores on the Patient Health Questionnaire (PHQ-9)
Period 3 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Day -1 (D-1) (ie, Period 1 Day-1 [P1D-1]), D6 (P2D1), D13 (P2D8), D20 (P2D15), D27 (P2D22), D37 (P3D1), D42 (P4D1), D50 (P4D9), D60 (P4D19), D66 (P5D6), and at follow-up visit (Days 72-75) of Part B.Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.
The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 \[not at all\] to 3 \[nearly every day\]. Higher score=greater severity).
Outcome measures
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=17 Participants
Participants received single dose of atorvastatin 20 mg orally on Day 1 in Part A Period 1.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
|---|---|---|---|---|---|---|---|---|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Not At All
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 1 Day -1 / 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 1 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 8 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 15 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Several Days
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Trouble Concentrating on Things · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Not At All
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 2 Day 22 / PF-06882961 titration up to 120 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy · Not At All
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating · More Than Half The Days
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Poor Appetite or Overeating · Nearly Every Day
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/ Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless · Not At All
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1/PF-06882961 120mg BID + 0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Not At All
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 3 Day 1 / PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Several Days
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Not At All
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 1 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Poor Appetite or Overeating · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 9 / PF-06882961 titration up to 200 mg BID / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Tired or Little Energy · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating · Not At All
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Poor Appetite or Overeating · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Moving Slowly or Fidgety/Restless · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 4 Day 19 / PF-06882961 titration up to 200 mg BID /Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Falling or Staying Asleep · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Tired or Little Energy · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating · Not At All
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating · More Than Half The Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Poor Appetite or Overeating · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things · Not At All
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Trouble Concentrating on Things · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6/PF-06882961 200mg BID+0.15mg LE & 0.03mg EE/Moving Slowly or Fidgety/Restless · Nearly Every Day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Not At All
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Period 5 Day 6 / PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Little Interest/Pleasure in Things · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Little Interest/Pleasure in Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Little Interest/Pleasure in Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Little Interest/Pleasure in Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Down Depressed or Hopeless · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Down Depressed or Hopeless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Down Depressed or Hopeless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Down Depressed or Hopeless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Trouble Falling or Staying Asleep · Not At All
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Trouble Falling or Staying Asleep · Several Days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Trouble Falling or Staying Asleep · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Trouble Falling or Staying Asleep · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Tired or Little Energy · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Tired or Little Energy · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Tired or Little Energy · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Tired or Little Energy · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Poor Appetite or Overeating · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Poor Appetite or Overeating · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Poor Appetite or Overeating · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Poor Appetite or Overeating · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Bad About Yourself · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Bad About Yourself · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Bad About Yourself · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Feeling Bad About Yourself · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Trouble Concentrating on Things · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Trouble Concentrating on Things · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Trouble Concentrating on Things · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Trouble Concentrating on Things · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Moving Slowly or Fidgety/Restless · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Moving Slowly or Fidgety/Restless · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Moving Slowly or Fidgety/Restless · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Moving Slowly or Fidgety/Restless · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Thoughts You Be Better Off Dead · Not At All
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Thoughts You Be Better Off Dead · Several Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Thoughts You Be Better Off Dead · More Than Half The Days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
(Part B) Number of Participants With Categorical Scores on the PHQ-9
Follow Up / Thoughts You Be Better Off Dead · Nearly Every Day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Atorvastatin 20 mg (Part A Period 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Midazolam 5 mg (Part A Period 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-06882961 Titration up to 120 mg BID (Part A Period 3)
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
0.15 mg LE & 0.03 mg EE (Part B Period 1)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06882961 Titration up to 120 mg BID (Part B Period 2)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-06882961 Titration up to 200 mg BID (Part B Period 4)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atorvastatin 20 mg (Part A Period 1)
n=18 participants at risk
Participants received single dose of atorvastatin 20 mg orally on Day 1 of Period 1 in Part A.
|
Midazolam 5 mg (Part A Period 2)
n=18 participants at risk
Participants received single dose of midazolam 5 mg orally on Day 1 of Period 2 in Part A.
|
PF-06882961 Titration up to 120 mg BID (Part A Period 3)
n=17 participants at risk
Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 3 in Part A.
|
PF-06882961 120 mg BID + Atorvastatin 20 mg (Part A Period 4)
n=13 participants at risk
Participants received PF-06882961 120 mg BID + atorvastatin 20 mg SD on Day 1 of Period 4 and PF-06882961 120 mg BID on Days 2-3 of Period 4 in Part A.
|
PF-06882961 120 mg BID + Midazolam 5 mg (Part A Period 5)
n=13 participants at risk
Participants received PF-06882961 120 mg BID + midazolam 5 mg SD on Day 1 of Period 5 in Part A.
|
PF-06882961 Titration up to 200 mg BID (Part A Period 6)
n=13 participants at risk
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 6 in Part A.
|
PF-06882961 200 mg BID + Atorvastatin 20 mg (Part A Period 7)
n=5 participants at risk
Participants received PF-06882961 200 mg BID + atorvastatin 20 mg SD on Day 1 of Period 7 and PF-06882961 200 mg BID on Days 2-3 of Period 7 in Part A.
|
PF-06882961 200 mg BID + Midazolam 5 mg (Part A Period 8)
n=6 participants at risk
Participants received PF-06882961 200 mg BID + midazolam 5 mg SD on Day 1 of Period 8 in Part A.
|
0.15 mg LE & 0.03 mg EE (Part B Period 1)
n=17 participants at risk
Participants received single dose of oral contraceptive on Day 1 of Period 1 in Part B.
|
PF-06882961 Titration up to 120 mg BID (Part B Period 2)
n=16 participants at risk
Participants received PF-06882961 10 mg BID on Days 1-4, 20 mg BID on Days 5-8, 40 mg BID on Days 9-12, 60 mg BID on Days 13-16, 80 mg BID on Days 17-20, 100 mg BID on Days 21-24, and 120 mg BID on Days 25-31 of Period 2 in Part B.
|
PF-06882961 120 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 3)
n=14 participants at risk
Participants received PF-06882961 120 mg BID + OC SD on Day 1 and PF-06882961 120 mg BID on Days 2-5 of Period 3 in Part B.
|
PF-06882961 Titration up to 200 mg BID (Part B Period 4)
n=12 participants at risk
Participants received PF-06882961 140 mg BID on Days 1-4, 160 mg BID on Days 5-8, 180 mg BID on Days 9-12, and 200 mg BID on Days 13-19 of Period 4 in Part B.
|
PF-06882961 200 mg BID + 0.15 mg LE & 0.03 mg EE (Part B Period 5)
n=9 participants at risk
Participants received PF-06882961 200 mg BID + oral contraceptive SD on Day 1 and PF-06882961 200 mg BID on Days 2-5 of Period 5 in Part B.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Blood calcitonin increased
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.6%
1/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
1/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
29.4%
5/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
15.4%
2/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
43.8%
7/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.1%
1/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
33.3%
4/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
33.3%
3/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
2/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
35.3%
6/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
23.1%
3/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
30.8%
4/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
2/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
11.8%
2/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
12.5%
2/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.1%
1/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
58.8%
10/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
15.4%
2/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
23.1%
3/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
75.0%
12/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
22.2%
2/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
11.8%
2/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
38.5%
5/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
20.0%
1/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
31.2%
5/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.1%
1/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
25.0%
3/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
22.2%
2/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
General disorders
Fatigue
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
20.0%
1/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
1/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
11.1%
1/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
1/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
11.1%
1/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
12.5%
2/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
14.3%
2/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
17.6%
3/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
15.4%
2/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
25.0%
4/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.1%
1/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
11.1%
1/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
11.8%
2/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
1/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
18.8%
3/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.1%
1/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
25.0%
3/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.6%
1/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
17.6%
3/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
23.1%
3/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
20.0%
1/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
1/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
43.8%
7/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
21.4%
3/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
50.0%
6/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
33.3%
3/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
General disorders
Feeling jittery
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
1/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.6%
1/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
16.7%
1/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
11.8%
2/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
61.5%
8/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
60.0%
3/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.6%
1/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
7.7%
1/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
12.5%
2/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
18.8%
3/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
25.0%
3/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
22.2%
2/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
12.5%
2/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
12.5%
2/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Electric shock sensation
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
18.8%
3/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Psychiatric disorders
Self esteem decreased
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
5.9%
1/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
12.5%
2/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
8.3%
1/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
6.2%
1/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/18 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/13 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/5 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/6 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/17 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
12.5%
2/16 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/14 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/12 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
0.00%
0/9 • From Screening (Days 28 to -2) to follow-up telephone contact (Days 90 to 97) in Part A and from Screening (Days 28 to -2) to follow-up telephone contact (Days 94 to 101) in Part B of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER