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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

138 participants

Primary outcome timeframe

First Cycle, Day 1 up to Day 21

Results posted on

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

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

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

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 21

Population: 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

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

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

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

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

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

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

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

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 28

Population: 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

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

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

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

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

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

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 1

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

PF-06647020 0.5 mg/kg (Q3W Regimen)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

PF-06647020 1.25 mg/kg (Q3W Regimen)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

PF-06647020 2.1 mg/kg (Q3W Regimen)

Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths

PF-06647020 2.8 mg/kg (Q3W Regimen)

Serious events: 33 serious events
Other events: 93 other events
Deaths: 13 deaths

PF-06647020 3.7 mg/kg (Q3W Regimen)

Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths

PF-06647020 2.1 mg/kg (Q2W Regimen)

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

PF-06647020 2.8 mg/kg (Q2W Regimen)

Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths

PF-06647020 3.2 mg/kg (Q2W Regimen)

Serious events: 7 serious events
Other events: 12 other events
Deaths: 2 deaths

Serious adverse events

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

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

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc

Phone: 1-800-718-1021

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