Trial Outcomes & Findings for A Study Of PF-04449913 Administered Alone In Select Solid Tumors (NCT NCT01286467)
NCT ID: NCT01286467
Last Updated: 2024-03-06
Results Overview
Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade \>=3 neutropenic infection; (4) Grade \>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade \>=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Baseline up to end of Cycle 1 (Study Day 28)
Results posted on
2024-03-06
Participant Flow
All enrolled participants were assigned to PF-04449913 dose escalation cohorts.
Participant milestones
| Measure |
PF-04449913 80 mg
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
7
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
7
|
8
|
Reasons for withdrawal
| Measure |
PF-04449913 80 mg
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Disease progression
|
3
|
2
|
2
|
3
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
3
|
|
Overall Study
Study drug stop longer than 14 days
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study Of PF-04449913 Administered Alone In Select Solid Tumors
Baseline characteristics by cohort
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18 to 44 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Age, Customized
45 to 64 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Age, Customized
Greater than or equal to (>=) 65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of Cycle 1 (Study Day 28)Population: Per-Protocol Analysis Set: all enrolled participants who received at least 1 dose of study medication and did not have major treatment deviations during Cycle 1.
Any DLT event in Cycle 1: (1) Grade 4 neutropenia lasting more than 7 days; (2) Febrile neutropenia; (3) Grade \>=3 neutropenic infection; (4) Grade \>=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia lasting more than 7 days; (6) Grade \>=3 non-hematologic toxicity; (7) Failure to deliver at least 80% of the planned doses due to toxicities attributable to PF-04449913
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Number of Participants With First Cycle Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])Population: Safety Analysis Set: all enrolled participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade
Any AEs, Total
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade
Any AEs, Grade 1
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade
Any AEs, Grade 2
|
50.0 percentage of participants
|
50.0 percentage of participants
|
42.9 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade
Any AEs, Grade 3
|
25.0 percentage of participants
|
25.0 percentage of participants
|
14.3 percentage of participants
|
87.5 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade
Any AEs, Grade 4
|
0.0 percentage of participants
|
0.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatment-emergent Adverse Events (AEs), by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (Version 4.0) Grade
Any AEs, Grade 5
|
25.0 percentage of participants
|
25.0 percentage of participants
|
14.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 28 days post last dose of study medication (maximum duration: 14 cycles [each cycle of 28 days])Population: Safety Analysis Set: all enrolled participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-related AEs are events that were assessed by the investigator as related to study medication. If the same participant in a given treatment had more than one occurrence in the same preferred term event category, only the worst CTCAE grade was reported. Grades as per NCI CTCAE, v4.0 were classified as: Grade 1- mild, Grade 2- moderate, Grade 3- severe, Grade 4- life threatening, and Grade 5- death.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 5
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 1
|
50.0 percentage of participants
|
25.0 percentage of participants
|
42.9 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 2
|
25.0 percentage of participants
|
50.0 percentage of participants
|
57.1 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 3
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
62.5 percentage of participants
|
|
Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade
Any AEs, Grade 4
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Treatment-related AEs, by NCI CTCAE (Version 4.0) Grade
Any AEs, Total
|
75.0 percentage of participants
|
75.0 percentage of participants
|
100.0 percentage of participants
|
87.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Cycle 1/Day 15Population: Pharmacodynamic (PD) Analysis Set: all enrolled participants who received at least 1 dose of study medication, and had baseline and at least 1 on-treatment PD result.
Ribonucleic acid (RNA) was extracted from skin samples and complementary deoxyribonucleic acid (cDNA) was prepared. Gene expression was measured using custom Taqman low density array (TLDA) cards run on the Applied Biosystems ViiATM 7 system. The ratio for each participant at each dosing level was calculated at C1D15 to baseline assay readout (C1D1), and the mean of it is reported in this outcome measure.
Outcome measures
| Measure |
PF-04449913 80 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=5 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Hedgehog Biomarker Modulation: Relative GLI1 Gene Expression (Ratio) to Baseline for Normal Skin on Cycle 1/Day 15
|
0.1 ratio
Standard Deviation 0.01
|
0.1 ratio
Standard Deviation 0.09
|
0.1 ratio
Standard Deviation 0.04
|
0.1 ratio
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Cmax of PF-04449913 on Cycle 1/Day 1 has been reported.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 1
|
1161 nanogram/milliliter (ng/mL)
Standard Deviation 389
|
1126 nanogram/milliliter (ng/mL)
Standard Deviation 949
|
2624 nanogram/milliliter (ng/mL)
Standard Deviation 611
|
6299 nanogram/milliliter (ng/mL)
Standard Deviation 2661
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Cmax of PF-04449913 on Cycle 1/Day 25 has been reported.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) on Cycle 1/Day 25
|
1373 ng/mL
Standard Deviation 542
|
1567 ng/mL
Standard Deviation 475
|
3363 ng/mL
Standard Deviation 1716
|
4913 ng/mL
Standard Deviation 992
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Tmax of PF-04449913 on Cycle 1/Day 1 has been reported.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 1
|
1.5 hours
Interval 1.0 to 2.2
|
2 hours
Interval 1.0 to 8.0
|
2.1 hours
Interval 1.0 to 4.0
|
2 hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Tmax of PF-04449913 on Cycle 1/Day 25 has been reported.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) on Cycle 1/Day 25
|
1 hours
Interval 0.9 to 2.0
|
2 hours
Interval 2.0 to 10.0
|
2 hours
Interval 1.0 to 10.0
|
4 hours
Interval 1.0 to 10.0
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
AUCtau of PF-04449913 on Cycle 1/Day 1 has been reported. AUCtau is defined as area under the curve from time 0 to tau, where tau is the dosing interval of 24 hours.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 1
|
10510 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 3948
|
12540 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 8583
|
31160 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 11140
|
62550 nanogram*hour/milliliter (ng*hr/mL)
Standard Deviation 18031
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
AUCtau of PF-04449913 on Cycle 1/Day 25 has been reported. AUCtau is defined as area under the curve from time 0 to tau, where tau is the dosing interval of 24 hours.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Cycle 1/Day 25
|
13930 ng*hr/mL
Standard Deviation 6967
|
18670 ng*hr/mL
Standard Deviation 5050
|
46670 ng*hr/mL
Standard Deviation 20336
|
70600 ng*hr/mL
Standard Deviation 19636
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Plasma Decay Half-life (t1/2) on Cycle 1/Day 25
|
19 hours
Standard Deviation 5
|
21 hours
Standard Deviation 6.7
|
21 hours
Standard Deviation 4.9
|
18 hours
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) on Cycle 1/Day 25
|
7.2 liter/hour (L/hr)
Standard Deviation 4.2
|
9.1 liter/hour (L/hr)
Standard Deviation 2.9
|
8.0 liter/hour (L/hr)
Standard Deviation 3.5
|
9.6 liter/hour (L/hr)
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) on Cycle 1/Day 25
|
182 liter (L)
Standard Deviation 69
|
286 liter (L)
Standard Deviation 146
|
234 liter (L)
Standard Deviation 93
|
249 liter (L)
Standard Deviation 88
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 6, 10 and 24 hours post dose on Cycle 1/Day 1, and pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Accumulation ratio was calculated as AUCtau at steady state (Cycle 1/Day 25)/AUCtau on Study Day 1
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Accumulation Ratio (Rac) on Cycle 1/Day 25
|
1.4 ratio
Interval 0.9 to 1.6
|
2.2 ratio
Interval 1.3 to 4.4
|
1.7 ratio
Interval 0.6 to 2.9
|
1.6 ratio
Interval 0.7 to 1.8
|
SECONDARY outcome
Timeframe: Pre dose, 1, 2, 4, 10, 24, 48, 72 and 96 hours post dose on Cycle 1/Day 25Population: PK Analysis Set: all treated participants who had at least 1 of the PK parameters of interest. N=number of participants evaluable for the outcome measure
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=3 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=6 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Average Concentration at Steady State (Cavg) on Cycle 1/Day 25
|
580 ng/mL
Standard Deviation 290
|
777 ng/mL
Standard Deviation 211
|
1942 ng/mL
Standard Deviation 848
|
2943 ng/mL
Standard Deviation 820
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 14 (each cycle 28 days)Population: QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.
Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole (QT) was corrected for heart rate (QTc). QTc using Fridericia's formula (QTcF) was calculated. Participants with maximum increase from baseline of less than (\<) 30 millisecond (msec), 30 to \<60 msec and \>=60 msec were summarized.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Number of Participants With Increase From Baseline in Corrected QT Using Fridericia's Formula (QTcF) Interval
QTcF, maximum increase from baseline: 30-<60 msec
|
1 participants
|
0 participants
|
2 participants
|
5 participants
|
|
Number of Participants With Increase From Baseline in Corrected QT Using Fridericia's Formula (QTcF) Interval
QTcF, maximum increase from baseline: >=60 msec
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Increase From Baseline in Corrected QT Using Fridericia's Formula (QTcF) Interval
QTcF, maximum increase from baseline: <30 msec
|
3 participants
|
4 participants
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 14 (each cycle 28 days)Population: QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. QTcF was calculated. Participants with maximum decrease from baseline of \<30 msec, 30 to \<60 msec and \>=60 msec were summarized.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Number of Participants With Decrease From Baseline in QTcF Interval
QTcF, maximum decrease from baseline: <30 msec
|
4 participants
|
4 participants
|
6 participants
|
4 participants
|
|
Number of Participants With Decrease From Baseline in QTcF Interval
QTcF, maximum decrease from baseline: 30-<60 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Decrease From Baseline in QTcF Interval
QTcF, maximum decrease from baseline: >=60 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 14 (each cycle 28 days)Population: QTc Analysis Set: all enrolled participants who had at least 1 ECG assessment after receiving at least 1 dose of study medication.
Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. Participants with post-baseline absolute QTcF values \>=500 msec were summarized.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Number of Participants With Post-baseline QTcF Interval Greater Than or Equal to 500 Msec
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 14 (each cycle 28 days)Population: Efficacy Analysis Set: all enrolled participants who received at least 1 dose of study medication.
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions.
Outcome measures
| Measure |
PF-04449913 80 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 Participants
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 Participants
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 Participants
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Percentage of Participants With Objective Response
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 41.0
|
0 percentage of participants
Interval 0.0 to 36.9
|
SECONDARY outcome
Timeframe: Baseline up to Cycle 14 (each cycle 28 days)Population: This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for progression free survival and thus the outcome measure was not performed.
Time from Cycle 1/Day 1 to first documentation of disease progression or to death due to any cause, whichever occurred first. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. PFS (days) was calculated as (first event date minus the date of first dose of study medication plus 1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Cycle 14 (each cycle 28 days)Population: This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for time to progression and thus the outcome measure was not performed.
Time from Cycle 1/Day 1 to first documentation of disease progression. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. TTP (days) was calculated as (first event date minus the date of first dose of study medication plus 1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to Cycle 14 (each cycle 28 days)Population: This OM was planned for expansion cohort only. Since none of the participants were enrolled in expansion cohort, no data was collected for duration of response and thus the outcome measure was not performed.
Duration from date of first documentation of objective response to date of first documentation of disease progression or death. Progression was defined using RECIST 1.1 as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm. DR was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first objective response that was subsequently confirmed plus 1).
Outcome measures
Outcome data not reported
Adverse Events
PF-04449913 80 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-04449913 160 mg
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
PF-04449913 320 mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-04449913 640 mg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-04449913 80 mg
n=4 participants at risk
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 participants at risk
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 participants at risk
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 participants at risk
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Chills
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Disease progression
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Pain
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Pyrexia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Peritonitis bacterial
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Pneumonia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Cerebrovascular accident
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Dyspnoea
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
PF-04449913 80 mg
n=4 participants at risk
Participants received oral single agent PF-04449913 tablets 80 milligram (mg) once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of pharmacokinetic (PK) assessments, and for 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 160 mg
n=4 participants at risk
Participants received oral single agent PF-04449913 tablets 160 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 320 mg
n=7 participants at risk
Participants received oral single agent PF-04449913 tablets 320 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
PF-04449913 640 mg
n=8 participants at risk
Participants received oral single agent PF-04449913 tablets 640 mg once daily for 25 days in Cycle 1 followed by 3 days without treatment for the purpose of PK assessments, and 28 days in Cycles 2 and beyond, i.e. up to a maximum of 14 treatment cycles (one treatment cycle was defined as 28 days).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Eye pain
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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 rigidity
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Ascites
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
62.5%
5/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
57.1%
4/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
62.5%
5/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Dry mouth
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Gastrooesophageal reflux disease
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Lip dry
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
4/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Parotid gland inflammation
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Stomatitis
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Asthenia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Chest pain
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Chills
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
50.0%
2/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
57.1%
4/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
75.0%
6/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Malaise
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Mucosal inflammation
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Oedema peripheral
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
2/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Respiratory tract infection viral
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Sinusitis
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Upper respiratory tract infection
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
50.0%
2/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Alanine aminotransferase increased
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Aspartate aminotransferase increased
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Blood alkaline phosphatase increased
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Blood bilirubin increased
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Blood creatinine increased
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Blood lactate dehydrogenase increased
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Blood uric acid increased
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Electrocardiogram QT interval abnormal
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Electrocardiogram QT prolonged
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Neutrophil count decreased
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Weight decreased
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
62.5%
5/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
4/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Arthralgia
|
50.0%
2/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Muscle atrophy
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Muscle spasms
|
50.0%
2/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Muscle twitching
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Musculoskeletal chest pain
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Myalgia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Pain in extremity
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Pain in jaw
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
62.5%
5/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Dysgeusia
|
75.0%
3/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
2/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
85.7%
6/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
50.0%
4/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Hypoaesthesia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Memory impairment
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Neuropathy peripheral
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Presyncope
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Syncope
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Cough
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Dysphonia
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Dyspnoea
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Hiccups
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Nasal congestion
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Upper-airway cough syndrome
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Actinic keratosis
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Alopecia
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
37.5%
3/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Dermatitis acneiform
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Dermatitis contact
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Dry skin
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Hyperhidrosis
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Onychoclasis
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
1/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Pruritus
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Pruritus generalised
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Rash
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
1/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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 hypopigmentation
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Hypertension
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Hypotension
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
25.0%
2/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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
Orthostatic hypotension
|
0.00%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/4
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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%
0/7
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
12.5%
1/8
The same event may appear as both an AE and a serious AE (SAE). However, what are presented are distinct events. An event may be categorized as serious 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