Trial Outcomes & Findings for Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers (NCT NCT01154218)
NCT ID: NCT01154218
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-∞).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 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
Results posted on
2011-10-24
Participant Flow
Participant milestones
| Measure |
Crizotinib 250 mg IRT Fasted, PIC Fasted, CIC Fasted, CIC Fed
Single oral dose of crizotinib 250 milligram (mg) immediate release tablet (IRT) in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg powder in capsule (PIC) in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg commercial image capsule (CIC) in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fed state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
|
Crizotinib 250 mg PIC Fasted, CIC Fed, IRT Fasted, CIC Fasted
Single oral dose of crizotinib 250 mg PIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in second intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
|
Crizotinib 250 mg CIC Fasted, IRT Fasted, CIC Fed, PIC Fasted
Single oral dose of crizotinib 250 mg CIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in third intervention period; and single oral dose of crizotinib 250 mg PIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
|
Crizotinib 250 mg CIC Fed, CIC Fasted, PIC Fasted, IRT Fasted
Single oral dose of crizotinib 250 mg CIC in fed state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg PIC in fasted state in third intervention period; and single oral dose of crizotinib 250 mg IRT in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
|
|---|---|---|---|---|
|
First Intervention Period
STARTED
|
9
|
9
|
9
|
9
|
|
First Intervention Period
COMPLETED
|
9
|
9
|
9
|
9
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period (at Least 14 Days)
STARTED
|
9
|
8
|
9
|
9
|
|
Washout Period (at Least 14 Days)
COMPLETED
|
9
|
8
|
9
|
8
|
|
Washout Period (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Second Intervention Period
STARTED
|
9
|
9
|
9
|
9
|
|
Second Intervention Period
COMPLETED
|
9
|
9
|
9
|
9
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Third Intervention Period
STARTED
|
9
|
9
|
9
|
9
|
|
Third Intervention Period
COMPLETED
|
9
|
8
|
9
|
9
|
|
Third Intervention Period
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Fourth Intervention Period
STARTED
|
9
|
8
|
9
|
8
|
|
Fourth Intervention Period
COMPLETED
|
8
|
8
|
9
|
8
|
|
Fourth Intervention Period
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Crizotinib 250 mg IRT Fasted, PIC Fasted, CIC Fasted, CIC Fed
Single oral dose of crizotinib 250 milligram (mg) immediate release tablet (IRT) in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg powder in capsule (PIC) in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg commercial image capsule (CIC) in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fed state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
|
Crizotinib 250 mg PIC Fasted, CIC Fed, IRT Fasted, CIC Fasted
Single oral dose of crizotinib 250 mg PIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in second intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
|
Crizotinib 250 mg CIC Fasted, IRT Fasted, CIC Fed, PIC Fasted
Single oral dose of crizotinib 250 mg CIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in third intervention period; and single oral dose of crizotinib 250 mg PIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
|
Crizotinib 250 mg CIC Fed, CIC Fasted, PIC Fasted, IRT Fasted
Single oral dose of crizotinib 250 mg CIC in fed state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg PIC in fasted state in third intervention period; and single oral dose of crizotinib 250 mg IRT in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
|
|---|---|---|---|---|
|
Third Intervention Period
Adverse Event
|
0
|
1
|
0
|
0
|
|
Washout Period (at Least 14 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
Fourth Intervention Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=36 Participants
Includes participants randomized to receive any treatment (crizotinib 250 mg IRT fasted first, crizotinib 250 mg PIC fasted first, crizotinib 250 mg CIC fasted first and crizotinib 250 mg CIC fed).
|
|---|---|
|
Age Continuous
|
38.9 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 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 dosePopulation: Pharmacokinetic (PK) parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])
|
2887.0 ng*hr/mL
Standard Deviation 1109.6
|
2890.0 ng*hr/mL
Standard Deviation 1021.8
|
2665.0 ng*hr/mL
Standard Deviation 1190.4
|
2475.0 ng*hr/mL
Standard Deviation 1037.7
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
135.00 ng/mL
Standard Deviation 47.84
|
126.00 ng/mL
Standard Deviation 36.58
|
119.30 ng/mL
Standard Deviation 50.88
|
116.10 ng/mL
Standard Deviation 45.58
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
2761.0 ng*hr/mL
Standard Deviation 1078.4
|
2763.0 ng*hr/mL
Standard Deviation 989.0
|
2531.0 ng*hr/mL
Standard Deviation 1158.0
|
2359.0 ng*hr/mL
Standard Deviation 1013.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
5.00 hr
Interval 2.0 to 6.0
|
5.00 hr
Interval 1.0 to 8.0
|
5.00 hr
Interval 2.0 to 6.0
|
5.00 hr
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Plasma Decay Half Life (t1/2)
|
34.85 hr
Standard Deviation 4.94
|
34.62 hr
Standard Deviation 4.13
|
35.28 hr
Standard Deviation 6.39
|
35.41 hr
Standard Deviation 5.49
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
Crizotinib CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
86.57 L/hr
Standard Deviation 53.63
|
86.49 L/hr
Standard Deviation 30.42
|
93.78 L/hr
Standard Deviation 49.80
|
101.00 L/hr
Standard Deviation 38.60
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
4313.0 L
Standard Deviation 3880.9
|
4290.0 L
Standard Deviation 1672.4
|
4703.0 L
Standard Deviation 2874.7
|
5096.0 L
Standard Deviation 2302.0
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)
|
436.90 ng*hr/mL
Standard Deviation 246.34
|
432.20 ng*hr/mL
Standard Deviation 219.76
|
391.20 ng*hr/mL
Standard Deviation 255.12
|
325.00 ng*hr/mL
Standard Deviation 192.81
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. Here, the 'N = 35' is signifying those participants who were evaluable for this measure at the specified time point for crizotinib CIC fed arm group.
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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)
|
447.10 ng*hr/mL
Standard Deviation 248.23
|
442.00 ng*hr/mL
Standard Deviation 221.96
|
402.10 ng*hr/mL
Standard Deviation 257.39
|
341.80 ng*hr/mL
Standard Deviation 194.91
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)
|
33.04 ng/mL
Standard Deviation 12.12
|
32.20 ng/mL
Standard Deviation 12.48
|
29.74 ng/mL
Standard Deviation 15.19
|
23.64 ng/mL
Standard Deviation 10.85
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96 and 144 hrs post crizotinib dosePopulation: PK parameter analysis population included all randomized 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 CIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib IRT Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=35 Participants
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 Participants
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)
|
5.00 hr
Interval 4.0 to 10.0
|
6.00 hr
Interval 4.0 to 8.02
|
6.00 hr
Interval 4.0 to 8.0
|
6.00 hr
Interval 2.0 to 10.0
|
Adverse Events
Crizotinib IRT Fasted
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Crizotinib PIC Fasted
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Crizotinib CIC Fasted
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Crizotinib CIC Fed
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crizotinib IRT Fasted
n=36 participants at risk
Single oral dose of crizotinib 250 mg IRT (Treatment A \[Reference 1\]) in fasted state in any intervention period.
|
Crizotinib PIC Fasted
n=36 participants at risk
Single oral dose of crizotinib 250 mg PIC (Treatment B \[Reference 2\]) in fasted state in any intervention period.
|
Crizotinib CIC Fasted
n=36 participants at risk
Single oral dose of crizotinib 250 mg CIC (Treatment C \[Test for bioequivalence (BE), Reference for Food effect\]) in fasted state in any intervention period.
|
Crizotinib CIC Fed
n=36 participants at risk
Single oral dose of crizotinib 250 mg CIC (Treatment D \[Test High Fat\]) in fed state in any intervention period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.8%
1/36
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.
|
2.8%
1/36
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.
|
2.8%
1/36
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%
0/36
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
|
0.00%
0/36
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.
|
2.8%
1/36
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%
0/36
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%
0/36
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
|
0.00%
0/36
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.
|
2.8%
1/36
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%
0/36
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.
|
5.6%
2/36
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
|
5.6%
2/36
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.
|
2.8%
1/36
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.
|
2.8%
1/36
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.
|
2.8%
1/36
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%
0/36
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.
|
2.8%
1/36
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%
0/36
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%
0/36
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
|
25.0%
9/36
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.
|
36.1%
13/36
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.
|
36.1%
13/36
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.
|
36.1%
13/36
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
Dyspepsia
|
0.00%
0/36
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%
0/36
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%
0/36
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.
|
2.8%
1/36
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
Epigastric discomfort
|
5.6%
2/36
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.
|
2.8%
1/36
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.
|
5.6%
2/36
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%
0/36
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
|
0.00%
0/36
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.
|
2.8%
1/36
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%
0/36
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.
|
2.8%
1/36
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
|
2.8%
1/36
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%
0/36
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.
|
2.8%
1/36
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.
|
5.6%
2/36
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
Gingivitis
|
0.00%
0/36
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%
0/36
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.
|
2.8%
1/36
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%
0/36
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
|
13.9%
5/36
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.
|
27.8%
10/36
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.
|
5.6%
2/36
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.
|
13.9%
5/36
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
Salivary hypersecretion
|
2.8%
1/36
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.
|
2.8%
1/36
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.
|
2.8%
1/36
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%
0/36
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
Vomiting
|
0.00%
0/36
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.
|
5.6%
2/36
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%
0/36
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%
0/36
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
|
8.3%
3/36
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.
|
13.9%
5/36
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.
|
5.6%
2/36
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.
|
2.8%
1/36
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%
0/36
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.
|
2.8%
1/36
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%
0/36
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%
0/36
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
|
5.6%
2/36
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.
|
8.3%
3/36
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%
0/36
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.
|
2.8%
1/36
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
Tooth abscess
|
0.00%
0/36
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%
0/36
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%
0/36
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.
|
2.8%
1/36
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
Urinary tract infection
|
0.00%
0/36
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%
0/36
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%
0/36
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.
|
2.8%
1/36
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.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
2.8%
1/36
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.
|
2.8%
1/36
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%
0/36
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%
0/36
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.
|
|
Investigations
Hepatic enzyme increased
|
2.8%
1/36
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%
0/36
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%
0/36
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%
0/36
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
Neck pain
|
0.00%
0/36
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.
|
2.8%
1/36
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%
0/36
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%
0/36
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
|
0.00%
0/36
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.
|
2.8%
1/36
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%
0/36
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%
0/36
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
|
0.00%
0/36
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.
|
2.8%
1/36
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%
0/36
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%
0/36
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
|
11.1%
4/36
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.
|
13.9%
5/36
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.
|
11.1%
4/36
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.
|
8.3%
3/36
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
Paraesthesia
|
2.8%
1/36
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.
|
2.8%
1/36
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.
|
2.8%
1/36
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.
|
2.8%
1/36
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
|
2.8%
1/36
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.
|
2.8%
1/36
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.
|
2.8%
1/36
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.
|
8.3%
3/36
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.
|
|
Vascular disorders
Hot flush
|
0.00%
0/36
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%
0/36
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%
0/36
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.
|
2.8%
1/36
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
- Publication restrictions are in place