Trial Outcomes & Findings for Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam (NCT NCT00952653)
NCT ID: NCT00952653
Last Updated: 2011-08-15
Results Overview
AUCinf measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing
Results posted on
2011-08-15
Participant Flow
Participant milestones
| Measure |
DVS SR 50 mg, Midazolam 4 mg
Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter \[mg/mL\]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|
|
Period 1: MDZ Alone
STARTED
|
28
|
|
Period 1: MDZ Alone
COMPLETED
|
28
|
|
Period 1: MDZ Alone
NOT COMPLETED
|
0
|
|
Period 2: Coadministration DVS SR, MDZ
STARTED
|
28
|
|
Period 2: Coadministration DVS SR, MDZ
COMPLETED
|
28
|
|
Period 2: Coadministration DVS SR, MDZ
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
Baseline characteristics by cohort
| Measure |
DVS SR 50 mg, Midazolam 4 mg
n=28 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|
|
Age, Customized
18 to 25 years
|
2 participants
n=99 Participants
|
|
Age, Customized
26 to 35 years
|
9 participants
n=99 Participants
|
|
Age, Customized
36 to 45 years
|
13 participants
n=99 Participants
|
|
Age, Customized
> 45 years
|
4 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population: all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.
AUCinf measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=25 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR
|
54.69 ng*hr/mL
Standard Deviation 26.670
|
39.45 ng*hr/mL
Standard Deviation 13.301
|
PRIMARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the mean.
Cmax measured as nanograms per milliliters (ng/mL).
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=26 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
|
21.20 ng/mL
Standard Deviation 7.1216
|
18.24 ng/mL
Standard Deviation 5.1116
|
PRIMARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the mean.
1-Hydroxy-Midazolam is an analyte of Midazolam.
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=26 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR
|
36.87 ng*hr/mL
Standard Deviation 28.230
|
30.74 ng*hr/mL
Standard Deviation 14.649
|
PRIMARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the mean.
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=26 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
|
14.93 ng/mL
Standard Deviation 6.5282
|
15.10 ng/mL
Standard Deviation 6.2472
|
SECONDARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the mean.
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=26 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR
|
52.85 ng*hr/mL
Standard Deviation 23.980
|
38.11 ng*hr/mL
Standard Deviation 12.522
|
SECONDARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the median.
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=26 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
|
0.517 hr
Interval 0.25 to 1.5
|
0.500 hr
Interval 0.25 to 1.02
|
SECONDARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the mean.
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=25 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
|
5.320 hr
Standard Deviation 1.5948
|
4.648 hr
Standard Deviation 1.7436
|
SECONDARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the mean.
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=26 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR
|
37.09 ng*hr/mL
Standard Deviation 25.371
|
32.42 ng*hr/mL
Standard Deviation 14.881
|
SECONDARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the median.
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=26 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=26 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
|
1.00 hr
Interval 0.25 to 1.5
|
0.500 hr
Interval 0.25 to 1.02
|
SECONDARY outcome
Timeframe: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosingPopulation: PK parameter analysis population; N=number of participants contributing to the mean.
Outcome measures
| Measure |
Midazolam 4 mg (Period 1)
n=21 Participants
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg, Midazolam 4 mg (Period 2)
n=20 Participants
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|
|
1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
|
5.396 hr
Standard Deviation 2.0638
|
4.616 hr
Standard Deviation 1.7976
|
Adverse Events
Midazolam 4 mg (Period 1)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
DVS SR 50 mg (Period 2 / Day 1 to Day 5)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Midazolam 4 mg (Period 1)
n=28 participants at risk
Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
|
DVS SR 50 mg (Period 2 / Day 1 to Day 5)
n=28 participants at risk
DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state).
|
DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)
n=28 participants at risk
DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
14.3%
4/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
7.1%
2/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
10.7%
3/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
General disorders
Fatigue
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
10.7%
3/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
14.3%
4/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
General disorders
Feeling abnormal
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
7.1%
2/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
General disorders
Feeling of relaxation
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
General disorders
Hunger
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
General disorders
Thirst
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
7.1%
2/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Nervous system disorders
Dizziness
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Nervous system disorders
Headache
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
21.4%
6/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Nervous system disorders
Somnolence
|
71.4%
20/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
71.4%
20/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
10.7%
3/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Psychiatric disorders
Middle insomnia
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
3.6%
1/28 • Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Participants are counted for each treatment sequence.
|
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