Trial Outcomes & Findings for Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule (NCT NCT01297595)
NCT ID: NCT01297595
Last Updated: 2012-02-16
Results Overview
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hours (hrs) post crizotinib dose
Results posted on
2012-02-16
Participant Flow
Participant milestones
| Measure |
Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF
Single oral dose of crizotinib 250 milligram (mg) formulated capsule (FC) in first intervention period; and single oral dose of crizotinib 250 mg oral liquid formulation (OLF) in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
|
Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC
Single oral dose of crizotinib 250 mg OLF in first intervention period; and single oral dose of crizotinib 250 mg FC in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
|
|---|---|---|
|
First Intervention Period
STARTED
|
11
|
11
|
|
First Intervention Period
COMPLETED
|
11
|
11
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
|
Washout Period (At Least 14 Days)
STARTED
|
11
|
11
|
|
Washout Period (At Least 14 Days)
COMPLETED
|
11
|
11
|
|
Washout Period (At Least 14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
11
|
11
|
|
Second Intervention Period
COMPLETED
|
11
|
11
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=22 Participants
Includes participants randomized to receive crizotinib 250 mg FC first and crizotinib 250 mg OLF first.
|
|---|---|
|
Age Continuous
|
38.0 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hours (hrs) post crizotinib dosePopulation: Pharmacokinetic (PK) parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)]
|
2833 ng*hr/mL
Standard Deviation 1099
|
2821 ng*hr/mL
Standard Deviation 1086
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
5.00 hr
Interval 2.0 to 6.0
|
5.00 hr
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
2696 ng*hr/mL
Standard Deviation 1073
|
2679 ng*hr/mL
Standard Deviation 1069
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
121.0 ng/mL
Standard Deviation 38.9
|
117.2 ng/mL
Standard Deviation 36.1
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Plasma Terminal Half-Life (t1/2)
|
35.58 hr
Standard Deviation 6.12
|
36.35 hr
Standard Deviation 5.64
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Drug clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the plasma. Clearance obtained after oral dose (apparent oral clearance \[CL/F\]) is influenced by the fraction of the dose absorbed (F).
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
88.21 Liter/hour (L/hr)
Standard Deviation 30.17
|
88.61 Liter/hour (L/hr)
Standard Deviation 28.96
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
4473 Liter
Standard Deviation 2089
|
4593 Liter
Standard Deviation 2108
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast) of Crizotinib metabolite (PF-06260182).
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)
|
429.5 ng*hr/mL
Standard Deviation 242.3
|
439.1 ng*hr/mL
Standard Deviation 271.5
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated 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.
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞) of crizotinib metabolite (PF-06260182).
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=21 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)
|
454.4 ng*hr/mL
Standard Deviation 242.1
|
446.7 ng*hr/mL
Standard Deviation 273.1
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)
|
30.98 ng/mL
Standard Deviation 10.39
|
32.56 ng/mL
Standard Deviation 10.75
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)
|
5.00 hr
Interval 4.0 to 6.0
|
5.00 hr
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Metabolite (PF-06260182) to parent (crizotinib) molar ratio of maximum observed plasma concentration (MRCmax).
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)
|
0.2482 Ratio
Standard Deviation 0.0349
|
0.2694 Ratio
Standard Deviation 0.0532
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Molar ratio of metabolite to parent area under the plasma concentration time-curve from time zero (pre-dose) to the last measured concentration (MRAUClast).
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=22 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)
|
0.1546 Ratio
Standard Deviation 0.0275
|
0.1589 Ratio
Standard Deviation 0.0274
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all participants randomized and treated 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.
Molar ratio of metabolite to parent area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0- ∞) \[MRAUC (0- ∞)\].
Outcome measures
| Measure |
Crizotinib 250 mg FC
n=21 Participants
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 Participants
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Infinite Time [MRAUC (0- ∞)]
|
0.1514 Ratio
Standard Deviation 0.0254
|
0.1535 Ratio
Standard Deviation 0.0259
|
Adverse Events
Crizotinib 250 mg FC
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Crizotinib 250 mg OLF
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crizotinib 250 mg FC
n=22 participants at risk
Single oral dose of crizotinib 250 mg FC \[Reference\] in either first intervention period or second intervention period.
|
Crizotinib 250 mg OLF
n=22 participants at risk
Single oral dose of crizotinib 250 mg OLF \[Test\] in either first intervention period or second intervention period.
|
|---|---|---|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/22
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.
|
9.1%
2/22
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.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/22
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.
|
9.1%
2/22
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.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/22
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.
|
4.5%
1/22
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
4.5%
1/22
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.
|
0.00%
0/22
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.2%
4/22
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.
|
31.8%
7/22
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.5%
1/22
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.
|
0.00%
0/22
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.9%
9/22
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.
|
45.5%
10/22
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.
|
|
Gastrointestinal disorders
Faeces discoloured
|
4.5%
1/22
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.
|
0.00%
0/22
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.
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
1/22
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.
|
0.00%
0/22
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.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
9.1%
2/22
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.
|
4.5%
1/22
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.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
6/22
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.
|
27.3%
6/22
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.
|
|
General disorders
Fatigue
|
4.5%
1/22
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.
|
4.5%
1/22
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.
|
|
General disorders
Feeling cold
|
0.00%
0/22
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.
|
4.5%
1/22
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.
|
|
General disorders
Influenza like illness
|
0.00%
0/22
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.
|
4.5%
1/22
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.
|
|
Infections and infestations
Gastroenteritis
|
4.5%
1/22
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.
|
0.00%
0/22
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.
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
1/22
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.
|
4.5%
1/22
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.
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22
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.
|
0.00%
0/22
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.
|
|
Nervous system disorders
Dizziness postural
|
4.5%
1/22
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.
|
0.00%
0/22
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.
|
|
Nervous system disorders
Headache
|
22.7%
5/22
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.
|
31.8%
7/22
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.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/22
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.
|
4.5%
1/22
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.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/22
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.
|
4.5%
1/22
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.
|
|
Psychiatric disorders
Abnormal dreams
|
4.5%
1/22
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.
|
4.5%
1/22
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.
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/22
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.
|
4.5%
1/22
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.
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22
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.
|
0.00%
0/22
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.5%
1/22
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.
|
0.00%
0/22
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.
|
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