Trial Outcomes & Findings for Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers (NCT NCT01149785)
NCT ID: NCT01149785
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
15 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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2
Results posted on
2011-10-24
Participant Flow
Participant milestones
| Measure |
Crizotinib 150 mg
Single oral dose of crizotinib 150 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 150 mg + Ketoconazole 200 mg BID
Ketoconazole 200 mg tablet twice daily (BID), orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period. A washout period of at least 14 days was maintained between each period.
|
|---|---|---|
|
First Intervention
STARTED
|
15
|
0
|
|
First Intervention
COMPLETED
|
15
|
0
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period of at Least 14 Days
STARTED
|
15
|
0
|
|
Washout Period of at Least 14 Days
COMPLETED
|
15
|
0
|
|
Washout Period of at Least 14 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
0
|
15
|
|
Second Intervention
COMPLETED
|
0
|
15
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=15 Participants
Includes participants randomized to receive Crizotinib 150 mg IRT first and then Crizotinib 150 mg + Ketoconazole 200 mg BID
|
|---|---|
|
Age Continuous
|
36.5 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 hrs post crizotinib dose in period 2Population: The pharmacokinetic (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.
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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-∞)]
|
1260.00 ng*hr/mL
Standard Deviation 318.04
|
3986.00 ng*hr/mL
Standard Deviation 1010.10
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
65.540 ng/mL
Standard Deviation 24.486
|
94.470 ng/mL
Standard Deviation 19.082
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
Area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration (AUClast).
Outcome measures
| Measure |
Crizotinib 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
|
1197.00 ng*hr/mL
Standard Deviation 308.18
|
3929.00 ng*hr/mL
Standard Deviation 1004.40
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
|
5.0 hr
Interval 2.0 to 5.0
|
6.0 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 dose in period 1 and day 0, 0 (pre-dose), 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Crizotinib 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Plasma Decay Half-Life (t1/2)
|
37.1300 hr
Standard Deviation 4.3606
|
54.8700 hr
Standard Deviation 6.2589
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Apparent Oral Clearance (CL/F)
|
122.600 L/hr
Standard Deviation 31.382
|
38.850 L/hr
Standard Deviation 10.413
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
6580.0 L
Standard Deviation 1881.8
|
3122.0 L
Standard Deviation 1131.2
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)
|
172.700 ng*hr/mL
Standard Deviation 56.751
|
897.400 ng*hr/mL
Standard Deviation 337.920
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 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)
|
178.100 ng*hr/mL
Standard Deviation 57.989
|
920.600 ng*hr/mL
Standard Deviation 343.420
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 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 6.0
|
8.0 hr
Interval 6.0 to 10.0
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)
|
16.6900 ng/mL
Standard Deviation 4.8538
|
26.9400 ng/mL
Standard Deviation 5.4113
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)
|
0.1399 Ratio
Standard Deviation 0.0194
|
0.2217 Ratio
Standard Deviation 0.0397
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
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 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Extrapolated Infinite Time [MRAUC(0-∞)]
|
0.1371 Ratio
Standard Deviation 0.0188
|
0.2239 Ratio
Standard Deviation 0.0398
|
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, 6, 8, 10, 12, 24, 48, 72, 96, 144, 192 and 312 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.
Metabolite to parent molar ratio of maximum observed plasma concentration (Cmax).
Outcome measures
| Measure |
Crizotinib 150 mg
n=15 Participants
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 Participants
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)
|
0.2469 Ratio
Standard Deviation 0.0634
|
0.2766 Ratio
Standard Deviation 0.0511
|
Adverse Events
Crizotinib 150 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Crizotinib 150 mg + Ketoconazole 200 mg BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Crizotinib 150 mg
n=15 participants at risk
Single oral dose of crizotinib 150 mg IRT in first intervention period \[Treatment A (Reference)\].
|
Crizotinib 150 mg + Ketoconazole 200 mg BID
n=15 participants at risk
Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period \[Treatment B (Test)\].
|
|---|---|---|
|
Eye disorders
Abnormal sensation in eye
|
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%
0/15
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.
|
|
Eye disorders
Conjunctival hyperaemia
|
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%
0/15
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.
|
|
Eye disorders
Diplopia
|
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%
0/15
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.
|
|
Eye disorders
Dry eye
|
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.
|
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.
|
|
Eye disorders
Vision blurred
|
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%
0/15
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.
|
|
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.
|
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
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.
|
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
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.
|
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.
|
|
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%
0/15
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.
|
|
General disorders
Nodule
|
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.
|
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.
|
|
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%
0/15
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
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.
|
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.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
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.
|
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.
|
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