Trial Outcomes & Findings for Estimation Of Effect Of Rifampin On Pharmacokinetics Of Crizotinib In Healthy Volunteers (NCT NCT01147055)
NCT ID: NCT01147055
Last Updated: 2011-10-24
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 - ∞).
COMPLETED
PHASE1
15 participants
0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2
2011-10-24
Participant Flow
Participant milestones
| Measure |
Crizotinib 250 mg
Single oral dose of crizotinib 250 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
|
Crizotinib 250 mg + Rifampin 600 mg
Single oral dose of rifampin 600 mg tablet in fasted state from Day 1 to Day 14. A single oral dose of crizotinib 250 mg IRTs was administered on Day 9 in second intervention period. A washout period of at least 14 days was maintained between each period.
|
|---|---|---|
|
First Intervention Period
STARTED
|
15
|
0
|
|
First Intervention Period
COMPLETED
|
14
|
0
|
|
First Intervention Period
NOT COMPLETED
|
1
|
0
|
|
Washout Period (at Least 14 Days)
STARTED
|
14
|
0
|
|
Washout Period (at Least 14 Days)
COMPLETED
|
14
|
0
|
|
Washout Period (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
0
|
14
|
|
Second Intervention Period
COMPLETED
|
0
|
14
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Crizotinib 250 mg
Single oral dose of crizotinib 250 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
|
Crizotinib 250 mg + Rifampin 600 mg
Single oral dose of rifampin 600 mg tablet in fasted state from Day 1 to Day 14. A single oral dose of crizotinib 250 mg IRTs was administered on Day 9 in second intervention period. A washout period of at least 14 days was maintained between each period.
|
|---|---|---|
|
First Intervention Period
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Estimation Of Effect Of Rifampin On Pharmacokinetics Of Crizotinib In Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=15 Participants
Includes participants randomized to receive crizotinib 250 mg IRT first and then crizotinib 250 mg + rifampin 600 mg.
|
|---|---|
|
Age Continuous
|
38.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hours (hrs) post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants 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
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
|
2192.00 ng*hr/mL
Standard Deviation 616.59
|
397.20 ng*hr/mL
Standard Deviation 106.12
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
102.10 ng/mL
Standard Deviation 35.64
|
32.06 ng/mL
Standard Deviation 11.23
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants 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
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
2103.00 ng*hr/mL
Standard Deviation 620.52
|
368.60 ng*hr/mL
Standard Deviation 101.93
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
5.0 hr
Interval 4.0 to 6.0
|
3.0 hr
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
33.07 hr
Standard Deviation 6.96
|
48.23 hr
Standard Deviation 5.62
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance obtained after oral dose CL/F is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
118.80 L/hr
Standard Deviation 37.39
|
648.60 L/hr
Standard Deviation 164.95
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants 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 blood 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
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
5940.0 L
Standard Deviation 3242.9
|
45720.0 L
Standard Deviation 15766.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants 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
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)
|
369.50 ng*hr/mL
Standard Deviation 119.58
|
20.28 ng*hr/mL
Standard Deviation 8.19
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants 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 - ∞) of crizotinib metabolite (PF-06260182). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)
|
378.60 ng*hr/mL
Standard Deviation 120.38
|
21.78 ng*hr/mL
Standard Deviation 8.98
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all participants enrolled 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
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)
|
5.0 hr
Interval 4.0 to 8.0
|
5.0 hr
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)
|
29.88 ng/mL
Standard Deviation 10.22
|
3.29 ng/mL
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants 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 zero (pre-dose) to the last measured concentration (MRAUClast).
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Metabolite to Parent Ratio Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)
|
0.1703 Ratio
Standard Deviation 0.0264
|
0.0533 Ratio
Standard Deviation 0.0112
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose) , 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants 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 curve from time zero to extrapolated infinite time \[MRAUC (0-∞)\].
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC (0 - ∞)]
|
0.1676 Ratio
Standard Deviation 0.0271
|
0.0532 Ratio
Standard Deviation 0.0113
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 1 and Day 0, 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dose in period 2Population: The PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period.
Metabolite to parent molar ratio of maximum observed plasma concentration (MRCmax).
Outcome measures
| Measure |
Crizotinib 250 mg
n=15 Participants
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 Participants
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)
|
0.2839 Ratio
Standard Deviation 0.0711
|
0.0996 Ratio
Standard Deviation 0.0382
|
Adverse Events
Crizotinib 250 mg
Crizotinib 250 mg + Rifampin 600 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crizotinib 250 mg
n=15 participants at risk
Single oral dose of crizotinib 250 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 250 mg + Rifampin 600 mg
n=14 participants at risk
Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Eye disorders
Eye swelling
|
0.00%
0/15
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%
0/14
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
Constipation
|
0.00%
0/15
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.
|
14.3%
2/14
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
|
13.3%
2/15
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.
|
7.1%
1/14
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
|
6.7%
1/15
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%
0/14
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15
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%
0/14
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
|
0.00%
0/15
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%
0/14
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
Epistaxis
|
6.7%
1/15
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%
0/14
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