Trial Outcomes & Findings for A Study Of PF-06647020 For Adult Patients With Advanced Solid Tumors (NCT NCT02222922)
NCT ID: NCT02222922
Last Updated: 2020-12-17
Results Overview
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 anemia; Grade \>=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade \>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin \>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.
COMPLETED
PHASE1
138 participants
First Cycle, Day 1 up to Day 21
2020-12-17
Participant Flow
Once every 3 weeks (Q3W) Regimen: A total of 113 participants were enrolled to study treatments and 1 participant in the PF-06647020 2.1 mg/kg treatment group didn't receive any study treatment. Once every 2 weeks (Q2W) Regimen: A total of 25 participants were enrolled to study treatments and all were treated with study drug.
Participant milestones
| Measure |
PF-06647020 0.2 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
|
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
|
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
5
|
96
|
6
|
3
|
10
|
12
|
|
Overall Study
Received Treatment
|
2
|
2
|
2
|
4
|
96
|
6
|
3
|
10
|
12
|
|
Overall Study
COMPLETED
|
1
|
2
|
1
|
2
|
58
|
3
|
1
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
3
|
38
|
3
|
2
|
4
|
6
|
Reasons for withdrawal
| Measure |
PF-06647020 0.2 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.1 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
|
PF-06647020 2.8 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
|
PF-06647020 3.2 mg/kg (Q2W Regimen)
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
9
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
2
|
10
|
2
|
2
|
4
|
1
|
|
Overall Study
Participant refused further follow-up
|
1
|
0
|
0
|
1
|
6
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
Baseline characteristics by cohort
| Measure |
PF-06647020 0.2 mg/kg (Q3W Regimen)
n=2 Participants
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
|
PF-06647020 2.1 mg/kg (Q2W Regimen)
n=3 Participants
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
|
PF-06647020 2.8 mg/kg (Q2W Regimen)
n=10 Participants
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 Participants
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 3.2 mg/kg (Q2W Regimen)
n=12 Participants
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Q3W Regimen
|
73.0 Years
STANDARD_DEVIATION 2.8 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
57.5 Years
STANDARD_DEVIATION 14.8 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
—
|
61.0 Years
STANDARD_DEVIATION 2.8 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
55.0 Years
STANDARD_DEVIATION 13.6 • n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
58.1 Years
STANDARD_DEVIATION 11.8 • n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
59.5 Years
STANDARD_DEVIATION 8.4 • n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
58.4 Years
STANDARD_DEVIATION 11.6 • n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Continuous
Q2W Regimen
|
—
|
—
|
64.0 Years
STANDARD_DEVIATION 2.6 • n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
65.5 Years
STANDARD_DEVIATION 8.9 • n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
—
|
—
|
—
|
65.6 Years
STANDARD_DEVIATION 8.0 • n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
65.4 Years
STANDARD_DEVIATION 7.8 • n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Customized
< 18 (Q3W Regimen)
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Customized
18-44 (Q3W Regimen)
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
16 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
16 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Customized
45-64 (Q3W Regimen)
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
3 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
49 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
4 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
59 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Customized
>= 65 (Q3W Regimen)
|
2 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
31 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
37 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Customized
< 18 (Q2W Regimen)
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Customized
18-44 (Q2W Regimen)
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Customized
45-64 (Q2W Regimen)
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
5 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
6 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
12 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Age, Customized
>= 65 (Q2W Regimen)
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
5 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
6 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
13 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Sex: Female, Male
Q3W Regimen · Female
|
2 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
3 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
80 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
5 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
92 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Sex: Female, Male
Q3W Regimen · Male
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
16 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
20 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Sex: Female, Male
Q2W Regimen · Female
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
3 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
10 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
11 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
24 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Sex: Female, Male
Q2W Regimen · Male
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q3W Regimen · American Indian or Alaska Native
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q3W Regimen · Asian
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q3W Regimen · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q3W Regimen · Black or African American
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
5 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
6 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q3W Regimen · White
|
2 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
3 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
88 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
6 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
103 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q3W Regimen · More than one race
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q3W Regimen · Unknown or Not Reported
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q2W Regimen · American Indian or Alaska Native
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q2W Regimen · Asian
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q2W Regimen · Native Hawaiian or Other Pacific Islander
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q2W Regimen · Black or African American
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q2W Regimen · White
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
8 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
11 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
21 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q2W Regimen · More than one race
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Race (NIH/OMB)
Q2W Regimen · Unknown or Not Reported
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
1 Participants
n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
0 Participants
n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
2 Participants
n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Weight Continuous
Q3W Regimen
|
49.2 kilogram (kg)
STANDARD_DEVIATION 10.2 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
68.8 kilogram (kg)
STANDARD_DEVIATION 21.9 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
—
|
68.7 kilogram (kg)
STANDARD_DEVIATION 5.2 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
80.7 kilogram (kg)
STANDARD_DEVIATION 27.3 • n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
69.9 kilogram (kg)
STANDARD_DEVIATION 16.4 • n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
72.2 kilogram (kg)
STANDARD_DEVIATION 14.2 • n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
70.0 kilogram (kg)
STANDARD_DEVIATION 16.6 • n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Weight Continuous
Q2W Regimen
|
—
|
—
|
68.4 kilogram (kg)
STANDARD_DEVIATION 23.8 • n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
78.1 kilogram (kg)
STANDARD_DEVIATION 25.5 • n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
—
|
—
|
—
|
68.3 kilogram (kg)
STANDARD_DEVIATION 22.5 • n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
72.3 kilogram (kg)
STANDARD_DEVIATION 23.4 • n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Body Mass Index (BMI) Continuous
Q3W Regimen
|
18.3 kg/m^2
STANDARD_DEVIATION 2.0 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
22.7 kg/m^2
STANDARD_DEVIATION 2.7 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
—
|
23.6 kg/m^2
STANDARD_DEVIATION 2.0 • n=2 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
27.6 kg/m^2
STANDARD_DEVIATION 7.7 • n=4 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
25.6 kg/m^2
STANDARD_DEVIATION 5.5 • n=96 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
26.2 kg/m^2
STANDARD_DEVIATION 4.7 • n=6 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
25.5 kg/m^2
STANDARD_DEVIATION 5.5 • n=112 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
|
Body Mass Index (BMI) Continuous
Q2W Regimen
|
—
|
—
|
24.9 kg/m^2
STANDARD_DEVIATION 7.1 • n=3 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
29.9 kg/m^2
STANDARD_DEVIATION 9.1 • n=10 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
—
|
—
|
—
|
—
|
25.6 kg/m^2
STANDARD_DEVIATION 8.8 • n=12 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
27.2 kg/m^2
STANDARD_DEVIATION 8.7 • n=25 Participants • Since the Q3W and Q2W regimens were assessed independently for the purpose of this study, therefore, baseline data for these regimens are presented in separate rows.
|
PRIMARY outcome
Timeframe: First Cycle, Day 1 up to Day 21Population: Participants enrolled in the dose escalation phase in Q3W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post-baseline disease assessment.
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 anemia; Grade \>=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade \>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin \>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=15 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)Population: All participants enrolled in Q3W regimen who received at least 1 full or partial 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. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)
AEs
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
96 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
33 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)
AEs
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
84 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)Population: All participants enrolled in Q3W regimen who received at least 1 full or partial 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. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 1 (all-causality)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 2 (all-causality)
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
18 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 3 (all-causality)
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
49 Participants
|
5 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 4 (all-causality)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
14 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 5 (all-causality)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Missing or Unknown (all-causality)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 1 (treatment-related)
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
23 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 2 (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
21 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 3 (treatment-related)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
28 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 4 (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Grade 5 (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
Missing or Unknown (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of treatment (approximately 32 months).Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=5 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
Anemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
Lymphopenia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
21 Participants
|
2 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
White blood cells
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
18 Participants
|
1 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
Platelets
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
Absolute neutrophils
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
28 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of treatment (approximately 32 months).Population: All participants enrolled in Q3W who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=5 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Hypokalemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Hypophosphatemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Aspartate aminotransferase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Hyperglycemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Alkaline phosphatase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Hyponatremia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Alanine aminotransferase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Hypoalbuminemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Total bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Hypercalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Hypomagnesemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Creatinine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Gamma glutamyl transferase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Hypocalcemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of treatment (approximately 32 months).Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=93 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=5 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to end of treatment (approximately 32 months).Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=91 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=5 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First cycle, Day 1 up to Day 28Population: All participants enrolled in Q2W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post baseline disease assessment.
A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay \>14 days because of hematologic AE; (2) Hepatic: including Grade\>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST\>=3.0 x ULN concurrent with elevation in bilirubin\>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade \>=3 headache lasting \>48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With DLTs - Q2W Regimen
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)Population: All participants enrolled in Q2W regimen who received at least 1 full or partial 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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)
AEs
|
3 Participants
|
10 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)
SAEs
|
1 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)
AEs
|
3 Participants
|
10 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)
SAEs
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)Population: All participants enrolled in Q2W regimen who received at least 1 full or partial 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. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 5 (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 1 (all-causality)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 2 (all-causality)
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 3 (all-causality)
|
1 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 4 (all-causality)
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 5 (all-causality)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Missing or Unknown (all-causality)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 1 (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 2 (treatment-related)
|
3 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 3 (treatment-related)
|
0 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Grade 4 (treatment-related)
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
Missing or Unknown (treatment-related)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline to end of treatment (approximately 19 months).Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen
Absolute neutrophils
|
0 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen
Lymphopenia
|
0 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen
White blood cells
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen
Anemia
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline to end of treatment (approximately 19 months).Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Hypokalemia
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Hyponatremia
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Hypomagnesemia
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Hypoalbuminemia
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Hypocalcemia
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Hypophosphatemia
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Alanine aminotransferase
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Aspartate aminotransferase
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Alkaline phosphatase
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline and Day 1 of Cycle 1Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From baseline to end of treatment (approximately 19 months).Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen
Cycle 1, Single Dose
|
NA microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4570 microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation 30
|
4782 microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation 61
|
6929 microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation 80
|
|
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4201 microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation 95
|
5834 microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation 60
|
NA microgram•hour/milliliter (µg•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen
Cycle 4, Multiple Dose
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
55.41 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 53
|
92.94 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 50
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
|
Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen
Cycle 1, Single Dose
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA microgram/milliliter (µg/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
65.77 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 25
|
79.77 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 45
|
96.11 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 47
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing).
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Clearance (CL) for PF-06647020 - Q3W Regimen
Cycle 1, Single Dose
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
0.03464 Liter/hour (L/hr)
Geometric Coefficient of Variation 27
|
0.03956 Liter/hour (L/hr)
Geometric Coefficient of Variation 60
|
0.03694 Liter/hour (L/hr)
Geometric Coefficient of Variation 72
|
|
Clearance (CL) for PF-06647020 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
0.03640 Liter/hour (L/hr)
Geometric Coefficient of Variation 42
|
0.03121 Liter/hour (L/hr)
Geometric Coefficient of Variation 60
|
NA Liter/hour (L/hr)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen
Cycle 1, Single Dose
|
NA Liter (L)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA Liter (L)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA Liter (L)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.498 Liter (L)
Geometric Coefficient of Variation 26
|
3.199 Liter (L)
Geometric Coefficient of Variation 40
|
3.947 Liter (L)
Geometric Coefficient of Variation 52
|
|
Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA Liter (L)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA Liter (L)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.230 Liter (L)
Geometric Coefficient of Variation 46
|
2.808 Liter (L)
Geometric Coefficient of Variation 47
|
NA Liter (L)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen
Cycle 1, Single Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.600 day
Standard Deviation 0.487
|
3.107 day
Standard Deviation 1.161
|
3.514 day
Standard Deviation 0.696
|
|
Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4.013 day
Standard Deviation 2.891
|
4.007 day
Standard Deviation 1.496
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=41 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
1.046 Ratio
Geometric Coefficient of Variation 61
|
1.094 Ratio
Geometric Coefficient of Variation 39
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen
Cycle 1, Single Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
2.48 hour
Interval 0.95 to 4.17
|
1.08 hour
Interval 0.95 to 70.3
|
2.49 hour
Interval 0.983 to 24.1
|
|
Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.05 hour
Interval 0.967 to 24.0
|
1.65 hour
Interval 0.917 to 48.2
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen
Cycle 1, Single Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4570 µg•hr/mL
Geometric Coefficient of Variation 30
|
4674 µg•hr/mL
Geometric Coefficient of Variation 63
|
4450 µg•hr/mL
Geometric Coefficient of Variation 198
|
|
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4157 µg•hr/mL
Geometric Coefficient of Variation 98
|
5428 µg•hr/mL
Geometric Coefficient of Variation 83
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06647020 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen
Cycle 1, Single Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4637 µg•hr/mL
Geometric Coefficient of Variation 30
|
4829 µg•hr/mL
Geometric Coefficient of Variation 63
|
7052 µg•hr/mL
Geometric Coefficient of Variation 81
|
|
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4312 µg•hr/mL
Geometric Coefficient of Variation 102
|
6086 µg•hr/mL
Geometric Coefficient of Variation 62
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCtau for PF-06380101 - Q3W Regimen
Cycle 1, Single Dose
|
NA nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
844.6 nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 46
|
803.9 nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 68
|
1022 nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 78
|
|
AUCtau for PF-06380101 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
418.3 nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 106
|
647.9 nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation 46
|
NA nanogram•hour/milliliter (ng•hr/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Cmax for PF-06380101 - Q3W Regimen
Cycle 1, Single Dose
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
7.156 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
6.934 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 69
|
7.660 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
|
Cmax for PF-06380101 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.379 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 84
|
5.746 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 60
|
NA nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
t1/2 for PF-06380101 - Q3W Regimen
Cycle 1, Single Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.150 day
Standard Deviation 0.426
|
2.881 day
Standard Deviation 0.604
|
3.210 day
Standard Deviation 0.473
|
|
t1/2 for PF-06380101 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
2.827 day
Standard Deviation 0.391
|
2.781 day
Standard Deviation 0.676
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=42 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Rac for PF-06380101 - Q3W Regimen
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
0.5454 Ratio
Geometric Coefficient of Variation 40
|
0.8916 Ratio
Geometric Coefficient of Variation 41
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Tmax for PF-06380101 - Q3W Regimen
Cycle 1, Single Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
23.6 hour
Interval 4.0 to 48.0
|
23.9 hour
Interval 3.9 to 141.0
|
23.4 hour
Interval 4.0 to 74.0
|
|
Tmax for PF-06380101 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
23.8 hour
Interval 23.6 to 24.0
|
21.9 hour
Interval 3.67 to 96.0
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUClast for PF-06380101 - Q3W Regimen
Cycle 1, Single Dose
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
844.6 ng•hr/mL
Geometric Coefficient of Variation 46
|
799.3 ng•hr/mL
Geometric Coefficient of Variation 68
|
490.5 ng•hr/mL
Geometric Coefficient of Variation 615
|
|
AUClast for PF-06380101 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
418.5 ng•hr/mL
Geometric Coefficient of Variation 106
|
643.6 ng•hr/mL
Geometric Coefficient of Variation 48
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06380101 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCinf for PF-06380101 - Q3W Regimen
Cycle 1, Single Dose
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
851.4 ng•hr/mL
Geometric Coefficient of Variation 45
|
812.2 ng•hr/mL
Geometric Coefficient of Variation 68
|
1020 ng•hr/mL
Geometric Coefficient of Variation 95
|
|
AUCinf for PF-06380101 - Q3W Regimen
Cycle 4, Multiple Dose
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
422.9 ng•hr/mL
Geometric Coefficient of Variation 105
|
645.2 ng•hr/mL
Geometric Coefficient of Variation 48
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mAb was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCtau for hu6M024 mAb - Q3W Regimen
Cycle 1, Single Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
6968 µg•hr/mL
Geometric Coefficient of Variation 32
|
5562 µg•hr/mL
Geometric Coefficient of Variation 62
|
8451 µg•hr/mL
Geometric Coefficient of Variation 78
|
|
AUCtau for hu6M024 mAb - Q3W Regimen
Cycle 4, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
6122 µg•hr/mL
Geometric Coefficient of Variation 145
|
6210 µg•hr/mL
Geometric Coefficient of Variation 80
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Cmax for hu6M024 mAb - Q3W Regimen
Cycle 1, Single Dose
|
NA µg/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
83.33 µg/mL
Geometric Coefficient of Variation 20
|
84.83 µg/mL
Geometric Coefficient of Variation 43
|
99.37 µg/mL
Geometric Coefficient of Variation 47
|
|
Cmax for hu6M024 mAb - Q3W Regimen
Cycle 4, Multiple Dose
|
NA µg/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA µg/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
77.76 µg/mL
Geometric Coefficient of Variation 76
|
82.33 µg/mL
Geometric Coefficient of Variation 40
|
NA µg/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
t1/2 for hu6M024 mAb - Q3W Regimen
Cycle 1, Single Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4.505 day
Standard Deviation 0.650
|
3.674 day
Standard Deviation 1.512
|
4.386 day
Standard Deviation 0.895
|
|
t1/2 for hu6M024 mAb - Q3W Regimen
Cycle 4, Multiple Dose
|
—
|
—
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
5.087 day
Standard Deviation 2.626
|
5.232 day
Standard Deviation 2.259
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=41 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Rac for hu6M024 mAb - Q3W Regimen
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
1.022 Ratio
Geometric Coefficient of Variation 108
|
0.9865 Ratio
Geometric Coefficient of Variation 48
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Tmax for hu6M024 mAb - Q3W Regimen
Cycle 1, Single Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4.00 hour
Interval 0.95 to 4.17
|
3.70 hour
Interval 0.933 to 24.1
|
2.31 hour
Interval 0.983 to 4.0
|
|
Tmax for hu6M024 mAb - Q3W Regimen
Cycle 4, Multiple Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.05 hour
Interval 1.0 to 23.6
|
3.90 hour
Interval 1.0 to 41.8
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUClast for hu6M024 mAb - Q3W Regimen
Cycle 1, Single Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
6969 µg•hr/mL
Geometric Coefficient of Variation 32
|
5449 µg•hr/mL
Geometric Coefficient of Variation 64
|
5247 µg•hr/mL
Geometric Coefficient of Variation 221
|
|
AUClast for hu6M024 mAb - Q3W Regimen
Cycle 4, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
—
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
6127 µg•hr/mL
Geometric Coefficient of Variation 147
|
5885 µg•hr/mL
Geometric Coefficient of Variation 97
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for hu6M024 mAb was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=85 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCinf for hu6M024 mAb - Q3W Regimen
Cycle 1, Single Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
7189 µg•hr/mL
Geometric Coefficient of Variation 32
|
5608 µg•hr/mL
Geometric Coefficient of Variation 65
|
8760 µg•hr/mL
Geometric Coefficient of Variation 80
|
|
AUCinf for hu6M024 mAb - Q3W Regimen
Cycle 4, Multiple Dose
|
—
|
—
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
6517 µg•hr/mL
Geometric Coefficient of Variation 156
|
6191 µg•hr/mL
Geometric Coefficient of Variation 94
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
SECONDARY outcome
Timeframe: Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months).Population: All participants enrolled in Q3W regimen who received at least 1 dose of study treatment and had at least 1 ADA sample collected.
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen
Overall incidence of ADA
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen
Overall incidence of NAb
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Population: Participants enrolled in Q3W regimen with measurable disease (non-small cell lung cancer \[NSCLC\], ovarian cancer \[OVCA\], triple negative breast cancer \[TNBC\]) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=25 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=44 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=29 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response - Q3W Regimen
|
16.0 Percentage of participants
Interval 4.5 to 36.1
|
27.3 Percentage of participants
Interval 15.0 to 42.8
|
20.7 Percentage of participants
Interval 8.0 to 39.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment. DoR was only for the subset participants with an objective response.
Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=4 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Duration of Response - Q3W Regimen
|
5.7 month
Interval 1.5 to 9.9
|
4.2 month
Interval 2.8 to 8.3
|
4.3 month
Interval 1.3 to 10.2
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR, non-CR/non-PD or stable disease (SD) according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=25 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=44 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=29 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Disease Control Rate - Q3W Regimen
|
56.0 Percentage of participants
Interval 34.93 to 75.6
|
72.7 Percentage of participants
Interval 57.21 to 85.04
|
48.3 Percentage of participants
Interval 29.45 to 67.47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=25 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=44 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=29 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Time to Progression - Q3W Regimen
|
2.9 month
Interval 1.4 to 6.1
|
3.1 month
Interval 2.3 to 5.5
|
2.2 month
Interval 1.4 to 5.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=25 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=44 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=29 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival - Q3W Regimen
|
2.9 month
Interval 1.4 to 6.1
|
2.9 month
Interval 2.3 to 5.5
|
1.5 month
Interval 1.4 to 4.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: The drug-drug interaction (DDI) sub-study was determined to evaluate the effect of multiple dose fluconazole on the PK of PF-06380101 (payload), when fluconazole was co-administered with PF-06647020. The analysis population included participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=8 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study]
|
29.56 µg•hr/mL/mg
Geometric Coefficient of Variation 46
|
23.47 µg•hr/mL/mg
Geometric Coefficient of Variation 53
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study]
|
31.51 µg•hr/mL/mg
Geometric Coefficient of Variation 51
|
24.34 µg•hr/mL/mg
Geometric Coefficient of Variation 50
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study]
|
29.25 µg•hr/mL/mg
Geometric Coefficient of Variation 46
|
24.85 µg•hr/mL/mg
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study]
|
0.5010 µg/mL/mg
Geometric Coefficient of Variation 49
|
0.4425 µg/mL/mg
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCinf(dn) for PF-06380101 [DDI Sub-Study]
|
5.787 ng•hr/mL/mg
Geometric Coefficient of Variation 116
|
5.275 ng•hr/mL/mg
Geometric Coefficient of Variation 123
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUClast(dn) for PF-06380101 [DDI Sub-Study]
|
5.681 ng•hr/mL/mg
Geometric Coefficient of Variation 112
|
5.089 ng•hr/mL/mg
Geometric Coefficient of Variation 128
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCtau(dn) for PF-06380101 [DDI Sub-Study]
|
5.746 ng•hr/mL/mg
Geometric Coefficient of Variation 115
|
5.239 ng•hr/mL/mg
Geometric Coefficient of Variation 123
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Cmax(dn) for PF-06380101 [DDI Sub-Study]
|
0.04336 ng/mL/mg
Geometric Coefficient of Variation 113
|
0.04436 ng/mL/mg
Geometric Coefficient of Variation 118
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=9 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCinf(dn) for hu6M024 mAb [DDI Sub-Study]
|
31.94 µg•hr/mL/mg
Geometric Coefficient of Variation 45
|
25.92 µg•hr/mL/mg
Geometric Coefficient of Variation 46
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUClast(dn) for hu6M024 mAb [DDI Sub-Study]
|
31.30 µg•hr/mL/mg
Geometric Coefficient of Variation 44
|
26.30 µg•hr/mL/mg
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCtau(dn) for hu6M024 mAb [DDI Sub-Study]
|
31.29 µg•hr/mL/mg
Geometric Coefficient of Variation 44
|
26.96 µg•hr/mL/mg
Geometric Coefficient of Variation 46
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=11 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Cmax(dn) for hu6M024 mAb [DDI Sub-Study]
|
0.4378 µg/mL/mg
Geometric Coefficient of Variation 59
|
0.3885 µg/mL/mg
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCtau for PF-06647020 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
9858 µg•hr/mL
Geometric Coefficient of Variation 21
|
6933 µg•hr/mL
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
|
AUCtau for PF-06647020 - Q2W Regimen
Cycle 1, Single Dose
|
3627 µg•hr/mL
Geometric Coefficient of Variation 62
|
6541 µg•hr/mL
Geometric Coefficient of Variation 38
|
6319 µg•hr/mL
Geometric Coefficient of Variation 45
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Cmax for PF-06647020 -Q2W Regimen
Cycle 1, Single Dose
|
97.79 µg/mL
Geometric Coefficient of Variation 14
|
99.69 µg/mL
Geometric Coefficient of Variation 32
|
90.28 µg/mL
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
|
Cmax for PF-06647020 -Q2W Regimen
Cycle 3, Multiple Dose
|
NA µg/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
114.7 µg/mL
Geometric Coefficient of Variation 26
|
81.91 µg/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Vss for PF-06647020 - Q2W Regimen
Cycle 1, Single Dose
|
NA Liter
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
2.566 Liter
Geometric Coefficient of Variation 44
|
2.953 Liter
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
|
Vss for PF-06647020 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA Liter
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
2.349 Liter
Geometric Coefficient of Variation 24
|
3.106 Liter
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing).
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
CL for PF-06647020 - Q2W Regimen
Cycle 1, Single Dose
|
NA L/hr
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
0.03075 L/hr
Geometric Coefficient of Variation 49
|
0.03238 L/hr
Geometric Coefficient of Variation 39
|
—
|
—
|
—
|
|
CL for PF-06647020 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA L/hr
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
0.02044 L/hr
Geometric Coefficient of Variation 25
|
0.02688 L/hr
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
t1/2 for PF-06647020 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.633 day
Standard Deviation 0.415
|
3.600 day
Standard Deviation 0.583
|
—
|
—
|
—
|
|
t1/2 for PF-06647020 - Q2W Regimen
Cycle 1, Single Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
2.700 day
Standard Deviation 0.625
|
2.874 day
Standard Deviation 0.385
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=7 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Rac for PF-06647020 - Q2W Regimen
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
1.425 Ratio
Geometric Coefficient of Variation 35
|
1.211 Ratio
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Tmax for PF-06647020 - Q2W Regimen
Cycle 1, Single Dose
|
3.98 hour
Interval 0.983 to 4.02
|
2.45 hour
Interval 0.983 to 23.7
|
1.05 hour
Interval 0.9 to 4.0
|
—
|
—
|
—
|
|
Tmax for PF-06647020 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
1.07 hour
Interval 0.983 to 23.9
|
2.36 hour
Interval 0.983 to 4.03
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUClast for PF-06647020 - Q2W Regimen
Cycle 1, Single Dose
|
3641 µg•hr/mL
Geometric Coefficient of Variation 62
|
6490 µg•hr/mL
Geometric Coefficient of Variation 39
|
6342 µg•hr/mL
Geometric Coefficient of Variation 46
|
—
|
—
|
—
|
|
AUClast for PF-06647020 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
9864 µg•hr/mL
Geometric Coefficient of Variation 20
|
7000 µg•hr/mL
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCinf for PF-06647020 - Q2W Regimen
Cycle 1, Single Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
6798 µg•hr/mL
Geometric Coefficient of Variation 41
|
6535 µg•hr/mL
Geometric Coefficient of Variation 46
|
—
|
—
|
—
|
|
AUCinf for PF-06647020 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
10570 µg•hr/mL
Geometric Coefficient of Variation 22
|
7445 µg•hr/mL
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCtau for PF-06380101 - Q2W Regimen
Cycle 1, Single Dose
|
568.9 ng•hr/mL
Geometric Coefficient of Variation 12
|
860.3 ng•hr/mL
Geometric Coefficient of Variation 52
|
740.5 ng•hr/mL
Geometric Coefficient of Variation 62
|
—
|
—
|
—
|
|
AUCtau for PF-06380101 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
731.5 ng•hr/mL
Geometric Coefficient of Variation 61
|
589.8 ng•hr/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Cmax for PF-06380101 - Q2W Regimen
Cycle 1, Single Dose
|
6.084 ng/mL
Geometric Coefficient of Variation 59
|
6.665 ng/mL
Geometric Coefficient of Variation 49
|
5.779 ng/mL
Geometric Coefficient of Variation 59
|
—
|
—
|
—
|
|
Cmax for PF-06380101 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA ng/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4.857 ng/mL
Geometric Coefficient of Variation 66
|
4.248 ng/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
t1/2 for PF-06380101 - Q2W Regimen
Cycle 1, Single Dose
|
2.507 day
Standard Deviation 0.411
|
2.646 day
Standard Deviation 0.453
|
2.592 day
Standard Deviation 0.331
|
—
|
—
|
—
|
|
t1/2 for PF-06380101 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
2.755 day
Standard Deviation 0.653
|
3.007 day
Standard Deviation 0.373
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=7 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Rac for PF-06380101 - Q2W Regimen
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
0.9980 Ratio
Geometric Coefficient of Variation 26
|
0.9657 Ratio
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Tmax for PF-06380101 - Q2W Regimen
Cycle 1, Single Dose
|
3.98 hour
Interval 3.98 to 4.02
|
4.05 hour
Interval 3.75 to 72.1
|
24.7 hour
Interval 3.72 to 48.5
|
—
|
—
|
—
|
|
Tmax for PF-06380101 - Q2W Regimen
Cycle 3, Multiple Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
71.7 hour
Interval 3.75 to 166.0
|
22.8 hour
Interval 3.75 to 48.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUClast for PF-06380101- Q2W Regimen
Cycle 1, Single Dose
|
569.9 ng•hr/mL
Geometric Coefficient of Variation 12
|
866.0 ng•hr/mL
Geometric Coefficient of Variation 53
|
743.5 ng•hr/mL
Geometric Coefficient of Variation 63
|
—
|
—
|
—
|
|
AUClast for PF-06380101- Q2W Regimen
Cycle 3, Multiple Dose
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
728.9 ng•hr/mL
Geometric Coefficient of Variation 60
|
593.3 ng•hr/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCinf for PF-06380101- Q2W Regimen
Cycle 1, Single Dose
|
584.4 ng•hr/mL
Geometric Coefficient of Variation 11
|
888.5 ng•hr/mL
Geometric Coefficient of Variation 54
|
763.2 ng•hr/mL
Geometric Coefficient of Variation 62
|
—
|
—
|
—
|
|
AUCinf for PF-06380101- Q2W Regimen
Cycle 3, Multiple Dose
|
NA ng•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
738.8 ng•hr/mL
Geometric Coefficient of Variation 69
|
617.9 ng•hr/mL
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mA was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCtau for hu6M024 mAb- Q2W Regimen
Cycle 1, Single Dose
|
4089 µg•hr/mL
Geometric Coefficient of Variation 52
|
7325 µg•hr/mL
Geometric Coefficient of Variation 47
|
6911 µg•hr/mL
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
|
AUCtau for hu6M024 mAb- Q2W Regimen
Cycle 3, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
10440 µg•hr/mL
Geometric Coefficient of Variation 25
|
8432 µg•hr/mL
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Cmax for hu6M024 mAb -Q2W Regimen
Cycle 1, Single Dose
|
72.04 µg/mL
Geometric Coefficient of Variation 23
|
102.1 µg/mL
Geometric Coefficient of Variation 38
|
86.26 µg/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
|
Cmax for hu6M024 mAb -Q2W Regimen
Cycle 3, Multiple Dose
|
NA µg/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
106.6 µg/mL
Geometric Coefficient of Variation 37
|
89.66 µg/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
t1/2 for hu6M024 mAb - Q2W Regimen
Cycle 1, Single Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
3.436 day
Standard Deviation 0.750
|
3.645 day
Standard Deviation 0.752
|
—
|
—
|
—
|
|
t1/2 for hu6M024 mAb - Q2W Regimen
Cycle 3, Multiple Dose
|
NA day
Standard Deviation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
4.734 day
Standard Deviation 0.670
|
4.124 day
Standard Deviation 1.218
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=1 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=7 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Rac for hu6M024 mAb - Q2W Regimen
|
NA Ratio
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
1.280 Ratio
Geometric Coefficient of Variation 32
|
1.301 Ratio
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Tmax for hu6M024 mAb - Q2W Regimen
Cycle 1, Single Dose
|
3.98 hour
Interval 1.0 to 4.02
|
3.87 hour
Interval 0.983 to 4.35
|
1.05 hour
Interval 0.9 to 23.8
|
—
|
—
|
—
|
|
Tmax for hu6M024 mAb - Q2W Regimen
Cycle 3, Multiple Dose
|
NA hour
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
1.05 hour
Interval 0.95 to 3.92
|
2.36 hour
Interval 0.983 to 24.1
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUClast for hu6M024 mAb - Q2W Regimen
Cycle 1, Single Dose
|
4103 µg•hr/mL
Geometric Coefficient of Variation 52
|
7368 µg•hr/mL
Geometric Coefficient of Variation 46
|
6949 µg•hr/mL
Geometric Coefficient of Variation 45
|
—
|
—
|
—
|
|
AUClast for hu6M024 mAb - Q2W Regimen
Cycle 3, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
10460 µg•hr/mL
Geometric Coefficient of Variation 24
|
8555 µg•hr/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
AUCinf for hu6M024 mAb - Q2W Regimen
Cycle 1, Single Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
7742 µg•hr/mL
Geometric Coefficient of Variation 47
|
7411 µg•hr/mL
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
|
AUCinf for hu6M024 mAb - Q2W Regimen
Cycle 3, Multiple Dose
|
NA µg•hr/mL
Geometric Coefficient of Variation NA
NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.
|
10950 µg•hr/mL
Geometric Coefficient of Variation 22
|
8275 µg•hr/mL
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 hours before the first dose up to 30 days after the last dose (approximately 18 months).Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had at least 1 ADA sample collected.
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=3 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=10 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=12 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen
Overall incidence of ADA
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen
Overall incidence of NAb
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).Population: Participants enrolled in Q2W with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Percentage of participants with objective response based on assessment of CR or PR according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=19 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With Objective Response - Q2W Regimen
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment. DoR was only for the subset participants with an objective response.
For participants with an objective response, duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=2 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=5 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Duration of Response - Q2W Regimen
|
NA month
Interval 3.7 to
NA indicates not calculable. Number of participants with confirmed objective response was too small to provide such summary statistics.
|
6.5 month
Interval 3.9 to 8.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR or SD according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=19 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Disease Control Rate - Q2W Regimen
|
50 Percentage of participants
Interval 11.81 to 88.19
|
84.2 Percentage of participants
Interval 60.42 to 96.62
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=19 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Time to Progression - Q2W Regimen
|
2.7 month
Interval 1.0 to
NA indicates not calculable. Number of participants with PD was too small to provide such summary statistics.
|
3.8 month
Interval 3.1 to 7.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Outcome measures
| Measure |
PF-06647020 0.2 mg/kg(Q3W Regimen)
n=6 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=19 Participants
Participants enrolled in the dose escalation phase received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
Participants enrolled in the dose escalation phase received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
|
|---|---|---|---|---|---|---|
|
Progression Free Survival - Q2W Regimen
|
2.7 month
Interval 1.0 to
NA indicates not calculable. Number of participants with PD or death was too small to provide such summary statistics.
|
3.8 month
Interval 3.1 to 7.4
|
—
|
—
|
—
|
—
|
Adverse Events
PF-06647020 0.2 mg/kg (Q3W Regimen)
PF-06647020 0.5 mg/kg (Q3W Regimen)
PF-06647020 1.25 mg/kg (Q3W Regimen)
PF-06647020 2.1 mg/kg (Q3W Regimen)
PF-06647020 2.8 mg/kg (Q3W Regimen)
PF-06647020 3.7 mg/kg (Q3W Regimen)
PF-06647020 2.1 mg/kg (Q2W Regimen)
PF-06647020 2.8 mg/kg (Q2W Regimen)
PF-06647020 3.2 mg/kg (Q2W Regimen)
Serious adverse events
| Measure |
PF-06647020 0.2 mg/kg (Q3W Regimen)
n=2 participants at risk
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 participants at risk
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 participants at risk
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 participants at risk
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 participants at risk
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 participants at risk
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.1 mg/kg (Q2W Regimen)
n=3 participants at risk
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
|
PF-06647020 2.8 mg/kg (Q2W Regimen)
n=10 participants at risk
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
|
PF-06647020 3.2 mg/kg (Q2W Regimen)
n=12 participants at risk
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Neutropenic infection
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
PF-06647020 0.2 mg/kg (Q3W Regimen)
n=2 participants at risk
Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months.
|
PF-06647020 0.5 mg/kg (Q3W Regimen)
n=2 participants at risk
Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months.
|
PF-06647020 1.25 mg/kg (Q3W Regimen)
n=2 participants at risk
Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months.
|
PF-06647020 2.1 mg/kg (Q3W Regimen)
n=4 participants at risk
Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.8 mg/kg (Q3W Regimen)
n=96 participants at risk
Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months.
|
PF-06647020 3.7 mg/kg (Q3W Regimen)
n=6 participants at risk
Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months.
|
PF-06647020 2.1 mg/kg (Q2W Regimen)
n=3 participants at risk
Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months.
|
PF-06647020 2.8 mg/kg (Q2W Regimen)
n=10 participants at risk
Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months.
|
PF-06647020 3.2 mg/kg (Q2W Regimen)
n=12 participants at risk
Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.7%
17/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.2%
4/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
31.2%
30/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Cataract
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Macular oedema
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.2%
4/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.6%
15/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
6/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
34.4%
33/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
60.0%
6/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.3%
7/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
28.1%
27/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
6/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
47.9%
46/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
4/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.3%
7/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.5%
11/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
31.2%
30/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
6/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chills
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.2%
4/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
2/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
53.1%
51/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.3%
7/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Localised oedema
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
6/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.5%
11/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Breast cellulitis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
6/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
9/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
6/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
9/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.3%
7/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
31.2%
30/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
5/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
6/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.9%
21/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.7%
17/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
9/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
8/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
6/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.9%
21/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
41.7%
5/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.3%
7/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
9/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
6/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
17.7%
17/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
2/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
6/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.3%
7/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
36.5%
35/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
40.0%
4/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.3%
7/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
30.0%
3/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.6%
14/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
4/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
7.3%
7/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
8/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.2%
4/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
1.0%
1/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.4%
10/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
3.1%
3/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.4%
10/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
4.2%
4/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
42.7%
41/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
100.0%
3/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
80.0%
8/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
58.3%
7/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.4%
9/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
2/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
6.2%
6/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.2%
5/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
2.1%
2/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eye irritation
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eyelid rash
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
25.0%
3/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Catheter site erythema
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Catheter site pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Malaise
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/96 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.0%
1/10 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • From the time the participant took the first dose of study medication through the participant's last visit.(approximately 32 months)
MedDRA 22.1 coding dictionary was applied for all AE tables. The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious 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