Trial Outcomes & Findings for A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab (NCT NCT01307267)
NCT ID: NCT01307267
Last Updated: 2020-03-17
Results Overview
DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
190 participants
Primary outcome timeframe
Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days)
Results posted on
2020-03-17
Participant Flow
There was 1 participant who was enrolled but withdrew the consent before starting any of the treatment arms; therefore, this participant was not included in the participant flow table.
Participant milestones
| Measure |
Portion A: PF-05082566 0.006mg/kg
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.03mg/kg
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.06mg/kg
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.12mg/kg
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.18mg/kg
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.24mg/kg
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.3mg/kg
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.6mg/kg
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 2.4mg/kg
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 5mg/kg
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
6
|
4
|
3
|
42
|
3
|
4
|
31
|
5
|
6
|
11
|
3
|
3
|
4
|
3
|
3
|
3
|
4
|
32
|
3
|
5
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
1
|
2
|
1
|
1
|
0
|
1
|
0
|
0
|
0
|
2
|
3
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
5
|
3
|
1
|
41
|
2
|
4
|
30
|
5
|
6
|
11
|
1
|
0
|
2
|
1
|
1
|
1
|
2
|
32
|
3
|
5
|
4
|
Reasons for withdrawal
| Measure |
Portion A: PF-05082566 0.006mg/kg
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.03mg/kg
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.06mg/kg
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.12mg/kg
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.18mg/kg
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.24mg/kg
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.3mg/kg
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.6mg/kg
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 2.4mg/kg
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 5mg/kg
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
3
|
5
|
3
|
1
|
26
|
2
|
2
|
21
|
2
|
3
|
9
|
0
|
0
|
0
|
0
|
1
|
1
|
2
|
8
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
5
|
1
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
1
|
3
|
0
|
1
|
1
|
1
|
0
|
2
|
1
|
0
|
0
|
0
|
19
|
2
|
3
|
2
|
Baseline Characteristics
A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
Baseline characteristics by cohort
| Measure |
Portion A: PF-05082566 0.006mg/kg
n=4 Participants
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.03mg/kg
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.06mg/kg
n=6 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.12mg/kg
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.18mg/kg
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.24mg/kg
n=42 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.3mg/kg
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.6mg/kg
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 2.4mg/kg
n=5 Participants
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 5mg/kg
n=6 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Total
n=189 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
14 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
100 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
18 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
89 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
15 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
72 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
17 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
117 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
36 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
24 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
3 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
22 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
141 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
7 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
6 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
22 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
18 Participants
n=11 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days)Population: All participants who received at least 1 dose of PF-05082566 in the first 2 cycles of Portion A.
DLT: Any of the following adverse events (AEs) occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 alone for Portion A and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days)Population: All participants who received at least 1 dose of PF-05082566 and 1 dose of rituximab in the first 2 cycles of Portion B.
DLT: Any of the following AEs occurred in the first 2 cycles of treatment (up to 28 days post second dose) which was attributed to PF-05082566 in combination with rituximab for Portion B and not related to progressive disease. Hematologic: Grade 4 neutropenia lasting more than (\>)7 days; febrile neutropenia; neutropenic infection; Grade ≥3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade ≥3 hemolysis. Non-Hematologic: Grade ≥3 toxicities, except those Grade 3 events that responded to treatment (eg, Grade 3 nausea, vomiting, diarrhea responding to standard medical supportive care within 48 hours would not be considered a DLT). Severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). Each cycle=28 days.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With DLTs in First 2 Cycles of Portion B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of PF-05082566 in Portion A.
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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A
AEs
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
39 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
26 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A
SAEs
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
13 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A
AEs related to PF-05082566
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
25 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
10 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) in Portion A
SAEs related to PF-05082566
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of PF-05082566 in Portion A.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE).
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A
Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A
Grade 2
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
14 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A
Grade 3
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
12 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs by Maximum National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) Grade in Portion A
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of PF-05082566 in Portion A and had hematology laboratory test data.
Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=28 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
White blood cells, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Lymphopenia, Grade 2
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Anemia, Grade 1
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
20 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
12 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Anemia, Grade 2
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Anemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Lymphocyte count increased, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Lymphopenia, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Lymphopenia, Grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Lymphopenia, Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Neutrophils (absolute), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Neutrophils (absolute), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Neutrophils (absolute), Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Platelets, Grade 1
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
White blood cells, Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
White blood cells, Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: "Number of Participants Analyzed" represents all participants who received at least 1 dose of PF-05082566 in Portion A and had chemistries laboratory test data. "Number Analyzed" represents all participants who received at least 1 dose of PF-05082566 in Portion A and had data for the specified category.
Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=28 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
ALT, Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
ALT, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Alkaline phosphatase, Grade 1
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
13 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Alkaline phosphatase, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Alkaline phosphatase, Grade 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
AST, Grade 1
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
AST, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Bilirubin (total), Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Bilirubin (total), Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Creatinine, Grade 1
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
22 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
19 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Creatinine, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
GGT, Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
GGT, Grade 3
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypercalcemia, Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hyperglycemia, Grade 1
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
20 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
13 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hyperglycemia, Grade 2
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hyperglycemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hyperkalemia, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hyperkalemia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypermagnesemia, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypermagnesemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypernatremia, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypoalbuminemia, Grade 1
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
18 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypoalbuminemia, Grade 2
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypoalbuminemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypocalcemia, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypocalcemia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypocalcemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypoglycemia, Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypoglycemia, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypokalemia, Grade 1
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypokalemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypokalemia, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypomagnesemia, Grade 1
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hyponatremia, Grade 1
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
17 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hyponatremia, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypophosphatemia, Grade 2
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion A
Hypophosphatemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of PF-05082566 in Portion A.
For vital signs in Portion A, blood pressure and pulse rate were measured. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion A
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dosePopulation: All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Cmax of PF-05082566 was observed directly from data.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=40 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=29 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A
Cycle 1
|
0.1515 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 12
|
0.4952 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 34
|
1.014 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
2.614 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 23
|
4.219 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 16
|
3.246 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 30
|
11.72 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 28
|
97.75 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 13
|
7.038 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 23
|
49.63 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
18.02 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
150.3 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 Maximum Observed Serum Concentration (Cmax) in Portion A
Cycle 2
|
0.1250 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation NA
Geometric coefficient of variation (CV) was not calculated when there were less than 3 participants with data.
|
0.5049 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 7
|
1.093 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 47
|
3.408 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 25
|
4.013 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 25
|
2.955 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 46
|
14.80 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 24
|
101.6 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 17
|
8.349 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
58.38 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 33
|
17.61 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 36
|
167.0 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose of Cycle 2Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had data for Ctrough.
Ctrough of PF-05082566 was observed directly from data.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=37 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=24 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=10 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Pre-dose Trough Concentration During Multiple Dosing (Ctrough) in Portion A
|
NA μg/mL
Geometric Coefficient of Variation NA
Geometric mean cannot be calculated when there were participants with a zero value (ie, Ctrough below the limit of quantification). Geometric CV was not calculated when there were less than 3 participants with data.
|
0.1063 μg/mL
Geometric Coefficient of Variation 24
|
0.1092 μg/mL
Geometric Coefficient of Variation 24
|
0.3268 μg/mL
Geometric Coefficient of Variation 12
|
0.4285 μg/mL
Geometric Coefficient of Variation 49
|
0.3868 μg/mL
Geometric Coefficient of Variation 46
|
1.520 μg/mL
Geometric Coefficient of Variation 22
|
9.934 μg/mL
Geometric Coefficient of Variation 35
|
0.8597 μg/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
7.054 μg/mL
Geometric Coefficient of Variation 52
|
1.313 μg/mL
Geometric Coefficient of Variation 61
|
9.963 μg/mL
Geometric Coefficient of Variation 250
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Tmax of PF-05082566 was observed directly from data as time of Cmax.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=40 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=29 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A
Cycle 1
|
1.75 hours (hr)
Interval 1.5 to 2.0
|
1.63 hours (hr)
Interval 1.5 to 1.67
|
2.00 hours (hr)
Interval 1.0 to 5.42
|
1.26 hours (hr)
Interval 1.0 to 2.0
|
1.25 hours (hr)
Interval 0.967 to 6.0
|
1.03 hours (hr)
Interval 0.833 to 24.2
|
1.80 hours (hr)
Interval 1.62 to 2.0
|
1.06 hours (hr)
Interval 1.0 to 1.48
|
1.00 hours (hr)
Interval 1.0 to 1.5
|
1.50 hours (hr)
Interval 1.0 to 1.58
|
1.17 hours (hr)
Interval 1.0 to 5.53
|
1.50 hours (hr)
Interval 1.07 to 2.02
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 Time for Maximum Observed Serum Concentration (Tmax) in Portion A
Cycle 2
|
13.0 hours (hr)
Interval 2.0 to 24.0
|
1.50 hours (hr)
Interval 1.5 to 2.0
|
1.54 hours (hr)
Interval 1.0 to 2.0
|
1.00 hours (hr)
Interval 1.0 to 2.0
|
2.00 hours (hr)
Interval 1.5 to 2.0
|
1.03 hours (hr)
Interval 0.833 to 2.0
|
1.46 hours (hr)
Interval 1.0 to 1.7
|
1.92 hours (hr)
Interval 1.08 to 2.0
|
1.00 hours (hr)
Interval 1.0 to 1.0
|
1.08 hours (hr)
Interval 1.0 to 1.08
|
1.02 hours (hr)
Interval 0.883 to 1.22
|
1.31 hours (hr)
Interval 1.03 to 5.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
AUClast of PF-05082566 was determined by linear/log trapezoidal method.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=40 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=29 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Area Under the Serum Concentration-Time Profile (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) in Portion A
Cycle 1
|
8.212 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 251
|
101.0 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 9
|
148.1 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 33
|
389.4 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 58
|
703.3 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 32
|
481.1 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 48
|
2165 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 21
|
15540 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 22
|
996.1 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 29
|
5731 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 101
|
2383 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 61
|
25520 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 Area Under the Serum Concentration-Time Profile (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUClast) in Portion A
Cycle 2
|
14.21 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
105.2 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 49
|
93.59 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 152
|
614.9 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 7
|
808.0 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 53
|
818.7 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 38
|
1918 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 40
|
18140 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 24
|
1662 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
6741 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 6
|
4035 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 25
|
19900 microgram*hour per milliliter (μg*hr/mL)
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
AUCinf = AUClast + (Clast\*/kel), where Clast\* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=40 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=29 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A
Cycle 1
|
—
|
120 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
187.5 μg*hr/mL
Geometric Coefficient of Variation 31
|
667.0 μg*hr/mL
Geometric Coefficient of Variation 13
|
989.5 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
687.9 μg*hr/mL
Geometric Coefficient of Variation 43
|
2916 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
18430 μg*hr/mL
Geometric Coefficient of Variation 24
|
770.0 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
7628 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
3111 μg*hr/mL
Geometric Coefficient of Variation 36
|
28280 μg*hr/mL
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 AUC From Time 0 to Infinity (AUCinf) in Portion A
Cycle 2
|
—
|
169.8 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
251.4 μg*hr/mL
Geometric Coefficient of Variation 17
|
931.0 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
1072 μg*hr/mL
Geometric Coefficient of Variation 57
|
960.8 μg*hr/mL
Geometric Coefficient of Variation 47
|
1782 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
20950 μg*hr/mL
Geometric Coefficient of Variation 23
|
2000 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
8480 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
4649 μg*hr/mL
Geometric Coefficient of Variation 25
|
22400 μg*hr/mL
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
AUCtau of PF-05082566 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=40 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=29 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A
Cycle 1
|
13.70 μg*hr/mL
Geometric Coefficient of Variation 181
|
104.8 μg*hr/mL
Geometric Coefficient of Variation 9
|
154.2 μg*hr/mL
Geometric Coefficient of Variation 27
|
503.9 μg*hr/mL
Geometric Coefficient of Variation 14
|
690.9 μg*hr/mL
Geometric Coefficient of Variation 33
|
538.6 μg*hr/mL
Geometric Coefficient of Variation 33
|
2195 μg*hr/mL
Geometric Coefficient of Variation 21
|
15760 μg*hr/mL
Geometric Coefficient of Variation 20
|
1012 μg*hr/mL
Geometric Coefficient of Variation 27
|
8204 μg*hr/mL
Geometric Coefficient of Variation 36
|
2761 μg*hr/mL
Geometric Coefficient of Variation 34
|
25250 μg*hr/mL
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 AUC From Time 0 to Time of Dosing Interval (AUCtau) in Portion A
Cycle 2
|
—
|
130.8 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
224.4 μg*hr/mL
Geometric Coefficient of Variation 19
|
618.6 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
864.1 μg*hr/mL
Geometric Coefficient of Variation 47
|
824.3 μg*hr/mL
Geometric Coefficient of Variation 37
|
2107 μg*hr/mL
Geometric Coefficient of Variation 43
|
19040 μg*hr/mL
Geometric Coefficient of Variation 18
|
1681 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
7460 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
4068 μg*hr/mL
Geometric Coefficient of Variation 27
|
20490 μg*hr/mL
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2. It was reported in units of milliliter per hour per kilogram (mL/hr/kg).
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=40 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=29 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Clearance (CL) in Portion A
Cycle 1
|
—
|
0.2510 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.3203 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 31
|
0.1800 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 13
|
0.1823 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.3490 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 42
|
0.2054 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.2711 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 24
|
0.3890 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.3145 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.3861 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 36
|
0.3536 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 Clearance (CL) in Portion A
Cycle 2
|
—
|
0.2296 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.2676 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 19
|
0.1939 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.2082 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 47
|
0.2906 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 37
|
0.2847 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 43
|
0.2626 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 18
|
0.1786 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.3220 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.2950 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 27
|
0.4883 milliliter/hour/kilogram (mL/hr/kg)
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1 and Cycle 2 at pre-dose, and 1, 1.5, 2, 6, 24, 48, 168, 336 and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=40 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=29 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A
Cycle 1
|
—
|
65.50 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
101.1 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 20
|
83.63 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 15
|
74.38 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
110.7 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 28
|
82.38 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
97.07 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 26
|
75.20 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
110.4 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
112.2 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 29
|
125.5 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 Volume of Distribution at Steady State (Vss) in Portion A
Cycle 2
|
—
|
102.1 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
74.11 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 21
|
90.80 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
81.69 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 27
|
86.50 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 29
|
61.54 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
87.37 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 43
|
51.00 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
99.80 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
116.5 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 62
|
139.5 milliliter per kilogram (mL/kg)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of PF-05082566 in Portion A and was tested for ADA.
ADA for PF-05082566 was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer\>=6.23.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) for PF-05082566 in Portion A
|
4 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
20 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
14 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of PF-05082566 in Portion A and had post-baseline QTc data. "Number Analyzed" represents those participants who had data for each specified category.
Categorical summarization criteria for QTc interval (time from ECG Q wave to the end of the T wave corresponding to electrical systole corrected for heart rate): 1) absolute value of \>450 to \<=480 milliseconds (msec), \>480 to \<=500 msec, \>500 msec; 2) a maximum change from baseline of \>30 to \<=60 msec or \>60 msec.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=40 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=29 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A
QTc change >30 to <=60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A
QTc >450 to <=480 msec
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
10 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A
QTc >480 to <=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A
QTc >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion A
QTc change >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
Objective response: confirmed best overall response (BOR) of complete response (CR) or partial response (PR) per RECIST version 1.1. BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-progression of disease (non-PD), indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and \>=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Objective Response Per Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 in Portion A
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 97.5
|
4.8 percentage of participants
Interval 0.6 to 16.2
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
0 percentage of participants
Interval 0.0 to 45.9
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 52.2
|
0 percentage of participants
Interval 0.0 to 11.2
|
0 percentage of participants
Interval 0.0 to 28.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of PF-05082566 in Portion A and achieved an objective response. "Number analyzed" represents the number of such participants for each specified category.
Duration of response: the time from first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1) to the date of first documentation of objective progression of disease (PD) or death due to any cause. Objective PD per RECIST version 1.1: \>=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 millimeters (mm); or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions. This outcome measure reports the individual values for evaluable participants (instead of medians etc) due to the limited number of events.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response in Portion A
For Participant X in 0.24 mg/kg
|
—
|
—
|
—
|
—
|
—
|
5.8 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response in Portion A
For Participant Y in 0.24 mg/kg
|
—
|
—
|
—
|
—
|
—
|
24.2 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Duration of Response in Portion A
For Participant Z in 0.6 mg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
22.8 months
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of PF-05082566 in Portion A and and achieved an objective response.
Time to response: the time from Cycle 1 Day 1 to the first documentation of objective response (confirmed BOR of CR or PR per RECIST version 1.1). BOR of CR: target lesions and non-target diseases achieved CR, without new lesions. BOR of PR: target lesions achieved CR or PR while non-target diseases were non-CR/non-PD, indeterminate or missing, and without new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes decreased to normal size); PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target diseases, CR: disappearance of all non-target lesions and normalization of tumor marker levels; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits; Indeterminate: progression had not been determined and \>=1 non-target sites were not assessed or assessment methods were inconsistent with those used at baseline.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response in Portion A
|
—
|
—
|
—
|
—
|
—
|
10.3 months
Interval 2.3 to 18.4
|
1.8 months
Interval 1.8 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
Progression-free survival: the time from Cycle 1 Day 1 to the date of the first documentation of objective PD or death due to any cause, whichever occurred first. Objective PD per RECIST version 1.1: \>=20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy), with a minimum absolute increase of 5 mm; or unequivocal progression of pre-existing lesions for non-target disease; or appearance of new lesions.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival in Portion A
|
1.7 months
Interval 1.1 to 1.8
|
3.6 months
Interval 1.7 to 5.5
|
1.7 months
Interval 1.6 to 2.1
|
3.5 months
Interval 1.6 to
The upper limit of 95% confidence interval (CI) was not estimable due to the small number of events.
|
1.7 months
95% CI was not estimable due to the small number of events.
|
2.1 months
Interval 1.8 to 3.7
|
3.5 months
Interval 1.4 to
The upper limit of 95% CI was not estimable due to the small number of events.
|
3.3 months
Interval 0.3 to
The upper limit of 95% CI was not estimable due to the small number of events.
|
1.6 months
Interval 1.6 to 1.6
|
1.1 months
Interval 0.2 to 1.7
|
1.7 months
Interval 1.5 to 1.8
|
1.8 months
Interval 0.9 to 1.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of PF-05082566 in Portion A and had tumor assessments.
Overall survival was defined as the time from Cycle 1 Day 1 to the date of death due to any cause.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=42 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=6 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival in Portion A
|
4.6 months
Interval 2.1 to 6.2
|
4.0 months
Interval 3.6 to 29.7
|
7.6 months
Interval 4.2 to
Not estimable due to the small number of events.
|
13.3 months
Interval 5.9 to 24.1
|
5.9 months
Not estimable due to the small number of events.
|
9.0 months
Interval 5.8 to 16.4
|
NA months
Interval 3.9 to
Not estimable due to the small number of events.
|
29.5 months
Interval 1.8 to
Not estimable due to the small number of events.
|
24.5 months
Interval 1.6 to
Not estimable due to the small number of events.
|
11.2 months
Interval 3.7 to
Not estimable due to the small number of events.
|
7.6 months
Interval 2.9 to 12.7
|
6.1 months
Interval 3.9 to 7.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
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; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. AEs included both non-serious AEs and SAEs. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Causality of AEs was determined by the investigator.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs and SAEs in Portion B
SAEs related to rituximab
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs and SAEs in Portion B
AEs
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
30 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs and SAEs in Portion B
SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs and SAEs in Portion B
AEs related to PF-05082566
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
17 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs and SAEs in Portion B
SAEs related to PF-05082566
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs and SAEs in Portion B
AEs related to rituximab
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
17 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 4 yearsPopulation: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. Severity of AEs were graded according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE).
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B
Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B
Grade 2
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
17 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B
Grade 3
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B
Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Treatment-Emergent AEs by Maximum NCI CTCAE Grade in Portion B
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had hematology laboratory test data.
Following hematology laboratory abnormalities were graded per NCI CTCAE version 4.03: anemia, hemoglobin increased, lymphocyte count increased, lymphopenia, neutrophils (absolute), platelets, white blood cells. The abnormalities with at least 1 participant are presented here.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Platelets, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Lymphopenia, Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
White blood cells, Grade 1
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
11 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Lymphopenia, Grade 2
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Lymphocyte count increased, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Lymphopenia, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Neutrophils (absolute), Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
White blood cells, Grade 2
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Anemia, Grade 1
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
16 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Anemia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hemoglobin increased, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Neutrophils (absolute), Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Neutrophils (absolute), Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Neutrophils (absolute), Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Platelets, Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Platelets, Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Hematology Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
White blood cells, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had chemistries laboratory test data.
Following chemistries laboratory abnormalities were graded per NCI CTCAE version 4.03: alanine aminotransferase (ALT), Alkaline phosphatase, Aspartate aminotransferase (AST), bilirubin (total), creatinine, gamma glutamyl transferase (GGT), hypercalcemia, hyperglycemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, hypophosphatemia. The abnormalities with at least 1 participant are presented here.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypomagnesemia, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hyponatremia, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hyponatremia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
ALT, Grade 1
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
ALT, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
ALT, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Alkaline phosphatase, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
AST, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
AST, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Bilirubin (total), Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Bilirubin (total), Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Creatinine, Grade 1
|
2 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
27 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Creatinine, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypercalcemia, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hyperglycemia, Grade 1
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
9 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hyperglycemia, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hyperglycemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hyperkalemia, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hyperkalemia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hyperkalemia, Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypermagnesemia, Grade 1
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypermagnesemia, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypernatremia, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypernatremia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypoalbuminemia, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypoalbuminemia, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypocalcemia, Grade 1
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypocalcemia, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypocalcemia, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypoglycemia, Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypoglycemia, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypokalemia, Grade 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypophosphatemia, Grade 2
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Chemistries Laboratory Abnormalities by Maximum NCI CTCAE Grade in Portion B
Hypophosphatemia, Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B.
For vital signs in Portion B, blood pressure, pulse rate, and body temperature were measured. Clinical significance was determined by the investigator.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Sign Abnormalities in Portion B
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Cmax of PF-05082566 was observed directly from data.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=30 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Cmax in Portion B
Cycle 1
|
0.6284 μg/mL
Geometric Coefficient of Variation 11
|
1.569 μg/mL
Geometric Coefficient of Variation 12
|
2.673 μg/mL
Geometric Coefficient of Variation 26
|
4.167 μg/mL
Geometric Coefficient of Variation 12
|
4.512 μg/mL
Geometric Coefficient of Variation 29
|
7.435 μg/mL
Geometric Coefficient of Variation 9
|
19.20 μg/mL
Geometric Coefficient of Variation 27
|
196.2 μg/mL
Geometric Coefficient of Variation 22
|
12.16 μg/mL
Geometric Coefficient of Variation 9
|
89.06 μg/mL
Geometric Coefficient of Variation 23
|
42.61 μg/mL
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 Cmax in Portion B
Cycle 2
|
0.6838 μg/mL
Geometric Coefficient of Variation 18
|
1.948 μg/mL
Geometric Coefficient of Variation 6
|
3.102 μg/mL
Geometric Coefficient of Variation 18
|
3.934 μg/mL
Geometric Coefficient of Variation 28
|
4.607 μg/mL
Geometric Coefficient of Variation 30
|
6.481 μg/mL
Geometric Coefficient of Variation 10
|
20.03 μg/mL
Geometric Coefficient of Variation 32
|
206.0 μg/mL
Geometric Coefficient of Variation 29
|
13.97 μg/mL
Geometric Coefficient of Variation 24
|
95.16 μg/mL
Geometric Coefficient of Variation 19
|
44.35 μg/mL
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose of Cycle 2Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had data for Ctrough.
Ctrough of PF-05082566 was observed directly from data.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=27 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Ctrough in Portion B
|
0.1267 μg/mL
Geometric Coefficient of Variation 47
|
0.2853 μg/mL
Geometric Coefficient of Variation 23
|
0.3922 μg/mL
Geometric Coefficient of Variation 29
|
0.4698 μg/mL
Geometric Coefficient of Variation 53
|
0.3539 μg/mL
Geometric Coefficient of Variation 110
|
0.6001 μg/mL
Geometric Coefficient of Variation 48
|
1.452 μg/mL
Geometric Coefficient of Variation 62
|
31.34 μg/mL
Geometric Coefficient of Variation 36
|
1.486 μg/mL
Geometric Coefficient of Variation 90
|
12.16 μg/mL
Geometric Coefficient of Variation 63
|
5.560 μg/mL
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Tmax of PF-05082566 was observed directly from data as time of Cmax.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=30 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Tmax in Portion B
Cycle 2
|
1.05 hr
Interval 1.0 to 1.05
|
1.08 hr
Interval 1.0 to 1.55
|
1.04 hr
Interval 1.03 to 1.08
|
1.57 hr
Interval 1.07 to 21.1
|
1.00 hr
Interval 0.967 to 1.1
|
1.50 hr
Interval 0.967 to 1.5
|
1.02 hr
Interval 0.967 to 1.98
|
1.28 hr
Interval 1.0 to 1.5
|
1.33 hr
Interval 1.17 to 1.5
|
1.50 hr
Interval 1.0 to 1.5
|
1.50 hr
Interval 1.5 to 1.55
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 Tmax in Portion B
Cycle 1
|
1.50 hr
Interval 1.28 to 2.0
|
1.52 hr
Interval 1.0 to 1.83
|
1.06 hr
Interval 0.95 to 1.42
|
2.00 hr
Interval 1.5 to 2.0
|
1.52 hr
Interval 1.02 to 1.63
|
1.17 hr
Interval 1.0 to 1.52
|
1.06 hr
Interval 0.933 to 5.45
|
2.00 hr
Interval 1.0 to 6.1
|
2.00 hr
Interval 1.0 to 6.07
|
2.00 hr
Interval 1.5 to 6.0
|
2.00 hr
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
AUClast of PF-05082566 was determined by linear/log trapezoidal method.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=30 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 AUClast in Portion B
Cycle 2
|
176.2 μg*hr/mL
Geometric Coefficient of Variation 26
|
471.5 μg*hr/mL
Geometric Coefficient of Variation 7
|
696.5 μg*hr/mL
Geometric Coefficient of Variation 17
|
1146 μg*hr/mL
Geometric Coefficient of Variation 35
|
733.7 μg*hr/mL
Geometric Coefficient of Variation 85
|
1511 μg*hr/mL
Geometric Coefficient of Variation 10
|
6193 μg*hr/mL
Geometric Coefficient of Variation 22
|
48540 μg*hr/mL
Geometric Coefficient of Variation 27
|
3013 μg*hr/mL
Geometric Coefficient of Variation 70
|
19410 μg*hr/mL
Geometric Coefficient of Variation 37
|
10970 μg*hr/mL
Geometric Coefficient of Variation 44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 AUClast in Portion B
Cycle 1
|
121.1 μg*hr/mL
Geometric Coefficient of Variation 26
|
342.6 μg*hr/mL
Geometric Coefficient of Variation 13
|
513.7 μg*hr/mL
Geometric Coefficient of Variation 20
|
854.1 μg*hr/mL
Geometric Coefficient of Variation 31
|
701.7 μg*hr/mL
Geometric Coefficient of Variation 72
|
1130 μg*hr/mL
Geometric Coefficient of Variation 14
|
2772 μg*hr/mL
Geometric Coefficient of Variation 63
|
38180 μg*hr/mL
Geometric Coefficient of Variation 18
|
2373 μg*hr/mL
Geometric Coefficient of Variation 37
|
17120 μg*hr/mL
Geometric Coefficient of Variation 33
|
7955 μg*hr/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had AUCinf data.
AUCinf = AUClast + (Clast\*/kel), where Clast\* is the estimated concentration at the time of the last measurable concentration and kel is the terminal phase rate constant calculated as the absolute value of the slope of a linear regression during the terminal phase of the natural log-transformed concentration time profile.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=23 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=2 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 AUCinf in Portion B
|
137.8 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
407.0 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
615.5 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
1076 μg*hr/mL
Geometric Coefficient of Variation 38
|
824.1 μg*hr/mL
Geometric Coefficient of Variation 78
|
1421 μg*hr/mL
Geometric Coefficient of Variation 24
|
3703 μg*hr/mL
Geometric Coefficient of Variation 37
|
48870 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
2070 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
16790 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
9439 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
AUCtau of PF-05082566 was determined using linear/log trapezoidal method.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=30 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 AUCtau in Portion B
Cycle 1
|
125.0 μg*hr/mL
Geometric Coefficient of Variation 23
|
345.0 μg*hr/mL
Geometric Coefficient of Variation 16
|
514.5 μg*hr/mL
Geometric Coefficient of Variation 21
|
871.6 μg*hr/mL
Geometric Coefficient of Variation 32
|
712.0 μg*hr/mL
Geometric Coefficient of Variation 71
|
1128 μg*hr/mL
Geometric Coefficient of Variation 15
|
3206 μg*hr/mL
Geometric Coefficient of Variation 32
|
38860 μg*hr/mL
Geometric Coefficient of Variation 17
|
2361 μg*hr/mL
Geometric Coefficient of Variation 39
|
17290 μg*hr/mL
Geometric Coefficient of Variation 32
|
8001 μg*hr/mL
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 AUCtau in Portion B
Cycle 2
|
178.2 μg*hr/mL
Geometric Coefficient of Variation 26
|
453.9 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
701.8 μg*hr/mL
Geometric Coefficient of Variation 18
|
1072 μg*hr/mL
Geometric Coefficient of Variation 33
|
854.5 μg*hr/mL
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
1521 μg*hr/mL
Geometric Coefficient of Variation 10
|
5967 μg*hr/mL
Geometric Coefficient of Variation 30
|
48030 μg*hr/mL
Geometric Coefficient of Variation 16
|
3116 μg*hr/mL
Geometric Coefficient of Variation 63
|
18150 μg*hr/mL
Geometric Coefficient of Variation 39
|
10220 μg*hr/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
CL = Dose/AUCinf for Cycle 1 and Dose/AUCtau for Cycle 2.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=30 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 CL in Portion B
Cycle 1
|
0.2178 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.1470 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.1950 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.1667 mL/hr/kg
Geometric Coefficient of Variation 38
|
0.2911 mL/hr/kg
Geometric Coefficient of Variation 78
|
0.2107 mL/hr/kg
Geometric Coefficient of Variation 24
|
0.3241 mL/hr/kg
Geometric Coefficient of Variation 37
|
0.2048 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.2900 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.2973 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.2546 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 CL in Portion B
Cycle 2
|
0.1683 mL/hr/kg
Geometric Coefficient of Variation 26
|
0.1325 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.1710 mL/hr/kg
Geometric Coefficient of Variation 18
|
0.1681 mL/hr/kg
Geometric Coefficient of Variation 33
|
0.2807 mL/hr/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
0.1976 mL/hr/kg
Geometric Coefficient of Variation 11
|
0.2011 mL/hr/kg
Geometric Coefficient of Variation 30
|
0.2080 mL/hr/kg
Geometric Coefficient of Variation 16
|
0.1928 mL/hr/kg
Geometric Coefficient of Variation 63
|
0.2756 mL/hr/kg
Geometric Coefficient of Variation 39
|
0.2351 mL/hr/kg
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 144, 312, and 504 hours post-dose; Cycle 2 Day 1 pre-dose, 1.5, 2, 6, 24, 48, 168, 336, and 504 hours post-dose.Population: All participants who received at least 1 dose of PF-05082566 in Portion B and had at least 1 of the PK parameters of interest. "Number Analyzed" represents those participants who had data for each specified category.
Vss = CL × MRT, where CL is clearance and MRT is the mean residence time after intravenous administration.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=30 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PF-05082566 Vss in Portion B
Cycle 1
|
81.87 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
78.60 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
79.93 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
66.90 mL/kg
Geometric Coefficient of Variation 24
|
93.68 mL/kg
Geometric Coefficient of Variation 54
|
85.12 mL/kg
Geometric Coefficient of Variation 4
|
102.8 mL/kg
Geometric Coefficient of Variation 20
|
94.08 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
126.0 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
98.98 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
130.9 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PF-05082566 Vss in Portion B
Cycle 2
|
—
|
—
|
81.90 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
65.42 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
85.51 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
66.27 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
86.99 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
95.89 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
100.5 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
102.2 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
94.00 mL/kg
Geometric Coefficient of Variation NA
Geometric CV was not calculated when there were less than 3 participants with data.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose of Cycle 2Population: All participants who received at least 1 dose of rituximab in Portion B and had Cmax or Ctrough data for rituximab. No data were collected for this Outcome Measure.
Cmax and Ctrough of rituximab were observed directly from data.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and was tested for ADA. "Number Analyzed" represents those participants who had data for each specified category.
ADA for PF-05082566 and rituximab was detected using electrochemiluminescence assay. Positive ADA for PF-05082566: titer\>=6.23. Positive ADA for rituximab: titer\>=1.88.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B
For PF-05082566
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Positive ADA for PF-05082566 and Rituximab in Portion B
For rituximab
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had post-baseline QTc data. "Number Analyzed" represents those participants who had data for each specified category.
Categorical summarization criteria for QTc interval: 1) absolute value of \>450 to \<=480 milliseconds (msec), \>480 to \<=500 msec, \>500 msec; 2) a maximum change from baseline of \>30 to \<=60 msec or \>60 msec.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=2 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B
QTc change >60 msec
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B
QTc >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B
QTc change >30 to <=60 msec
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B
QTc >450 to <=480 msec
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
14 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With QTc Interval Meeting Categorical Summarization Criteria in Portion B
QTc >480 to <=500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.
Objective Response in Portion B was defined as BOR of CR or PR according to Cheson 2007 criteria. BOR of CR or PR per Cheson 2007: CR or PR of index lesions (complete disappearance of all detectable clinical and radiographic evidence of disease, all lymph nodes returned to normal size, spleen and/or liver if enlarged prior to therapy became normal or no longer palpable; or \>=50% decrease in the sum of the product diameters \[SPD\] of up to 6 index lesions, no increase in size of other nodes, liver or spleen), without PD of non-index lesions (ie, without: new nonnodal lesion, new nodal lesion \>=15 mm in greatest transverse diameter \[GTD\], unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), and without any new lesions.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving Objective Response Per Cheson 2007 Criteria in Portion B
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0 percentage of participants
Interval 0.0 to 70.8
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 70.8
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
0 percentage of participants
Interval 0.0 to 60.2
|
0 percentage of participants
Interval 0.0 to 60.2
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B, had tumor assessments for lymphoma, and achieved an objective response.
Duration of Response in Portion B was defined, for participants with an objective response (BOR of CR or PR per Cheson 2007 criteria), as the time from first documentation of objective response to the date of first documentation of objective PD or death due to any cause. Objective PD per Cheson 2007 was defined as: PD of index lesions (\>=50% increase in SPD of previously involved sites from nadir), or PD of non-index lesions (new nonnodal lesion, new nodal lesion \>=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), or appearance of new lesions.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=8 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=1 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response in Portion B
|
NA months
The median estimates of time to event, upper and lower limits of 95% CI were not estimable due to the small number of events.
|
—
|
NA months
The median estimates of time to event, upper and lower limits of 95% CI were not estimable due to the small number of events.
|
NA months
Interval 8.0 to
The median estimates of time to event and upper limit of 95% CI were not estimable due to the small number of events.
|
—
|
—
|
12.0 months
Interval 2.1 to
Not estimable due to the small number of events.
|
—
|
—
|
NA months
The median estimates of time to event, upper and lower limits of 95% CI were not estimable due to the small number of events.
|
9.5 months
Not estimable due to the small number of events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B, had tumor assessments for lymphoma, and achieved an objective response.
Time to response in Portion B was defined, for participants with an objective response (BOR of CR or PR per Cheson 2007 criteria), as the time from Cycle 1 Day 1 to the first documentation of objective response. BOR of CR or PR per Cheson 2007: CR or PR of index lesions (complete disappearance of all detectable clinical and radiographic evidence of disease, all lymph nodes returned to normal size, spleen and/or liver if enlarged prior to therapy became normal or no longer palpable; or \>=50% decrease in the SPD of up to 6 index lesions, no increase in size of other nodes, liver or spleen), without PD of non-index lesions (ie, without: new nonnodal lesion, new nodal lesion \>=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), and without any new lesions.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=2 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=8 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=1 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=1 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response in Portion B
|
2.1 months
Interval 2.1 to 2.1
|
—
|
2.1 months
Interval 2.1 to 2.1
|
2.0 months
Interval 1.9 to 2.1
|
—
|
—
|
2.1 months
Interval 1.9 to 2.2
|
—
|
—
|
7.4 months
Interval 7.4 to 7.4
|
3.9 months
Interval 3.9 to 3.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.
Progression-free survival in Portion B was defined as the time from Cycle 1 Day 1 to the date of the first documentation of objective PD (per Cheson 2007) or death due to any cause, whichever occurred first. Objective PD per Cheson 2007 was defined as: PD of index lesions (\>=50% increase in SPD of previously involved sites from nadir), or PD of non-index lesions (new nonnodal lesion, new nodal lesion \>=15 mm in GTD, unequivocal progression of existing non index lesions, bone marrow that was negative and is now positive, new circulating lymphoma cells in blood cell count and/or pleural fluid, new circulating blasts in the blood cell count), or appearance of new lesions.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression-Free Survival in Portion B
|
NA months
Interval 7.4 to
The median estimates of time to event and upper limit of 95% CI were not estimable due to the small number of events.
|
8.1 months
Interval 1.9 to 8.1
|
11.8 months
Interval 3.9 to
The upper limit of 95% CI was not estimable due to the small number of events.
|
9.9 months
Interval 6.0 to
The upper limit of 95% CI was not estimable due to the small number of events.
|
2.1 months
Interval 1.8 to 2.1
|
5.7 months
Interval 3.9 to
The upper limit of 95% CI was not estimable due to the small number of events.
|
3.9 months
Interval 2.1 to 5.7
|
3.0 months
Interval 2.1 to 4.2
|
4.8 months
Interval 0.7 to 9.4
|
3.9 months
Interval 2.1 to
The upper limit of 95% CI was not estimable due to the small number of events.
|
16.3 months
Interval 13.4 to 19.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Every 8 weeks from Cycle 1 Day 1 for the first 10 months on study treatment, then every 16 weeks till follow-up visit (assessed up to approximately 2 years)Population: All participants who received at least 1 dose of study treatment (PF-05082566 and/or rituximab) in Portion B and had tumor assessments for lymphoma.
Overall survival was defined as the time from Cycle 1 Day 1 to the date of death due to any cause.
Outcome measures
| Measure |
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 Participants
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=31 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 Participants
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 Participants
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=3 Participants
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival in Portion B
|
NA months
Not estimable due to the small number of events.
|
NA months
Not estimable due to the small number of events.
|
NA months
Not estimable due to the small number of events.
|
NA months
Not estimable due to the small number of events.
|
NA months
Interval 9.6 to
Not estimable due to the small number of events.
|
50.2 months
Not estimable due to the small number of events.
|
NA months
Interval 18.0 to
Not estimable due to the small number of events.
|
NA months
Interval 4.9 to
Not estimable due to the small number of events.
|
NA months
Interval 0.7 to
Not estimable due to the small number of events.
|
NA months
Interval 5.4 to
Not estimable due to the small number of events.
|
NA months
Interval 39.5 to
Not estimable due to the small number of events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 14, 29 and 57Population: This was an exploratory endpoint and no data were collected.
This was an exploratory endpoint and no data were collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1 and 21Population: This was an exploratory endpoint and no data were collected.
This was an exploratory endpoint and no data were collected.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2 yearsPopulation: This was an exploratory endpoint and was not evaluated. Patient-reported outcome questionnaires were not completed as a result of administrative processing error.
This was an exploratory endpoint and was not evaluated. Patient-reported outcome questionnaires were not completed as a result of administrative processing error.
Outcome measures
Outcome data not reported
Adverse Events
Portion A: PF-05082566 0.006mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 4 deaths
Portion A: PF-05082566 0.03mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Portion A: PF-05082566 0.06mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Portion A: PF-05082566 0.12mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Portion A: PF-05082566 0.18mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Portion A: PF-05082566 0.24mg/kg
Serious events: 13 serious events
Other events: 36 other events
Deaths: 27 deaths
Portion A: PF-05082566 0.3mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Portion A: PF-05082566 0.6mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Portion A: PF-05082566 1.2mg/kg
Serious events: 8 serious events
Other events: 23 other events
Deaths: 21 deaths
Portion A: PF-05082566 2.4mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Portion A: PF-05082566 5mg/kg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 3 deaths
Portion A: PF-05082566 10mg/kg
Serious events: 3 serious events
Other events: 9 other events
Deaths: 9 deaths
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
Serious events: 3 serious events
Other events: 29 other events
Deaths: 8 deaths
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Portion A: PF-05082566 0.006mg/kg
n=4 participants at risk
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.03mg/kg
n=3 participants at risk
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.06mg/kg
n=6 participants at risk
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.12mg/kg
n=4 participants at risk
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.18mg/kg
n=3 participants at risk
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.24mg/kg
n=42 participants at risk
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.3mg/kg
n=3 participants at risk
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.6mg/kg
n=4 participants at risk
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 participants at risk
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 2.4mg/kg
n=5 participants at risk
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 5mg/kg
n=6 participants at risk
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 participants at risk
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 participants at risk
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 participants at risk
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 participants at risk
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 participants at risk
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 participants at risk
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Disease progression
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 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%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cytomegalovirus chorioretinitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Portion A: PF-05082566 0.006mg/kg
n=4 participants at risk
Participants received PF-05082566 0.006 milligrams per kilogram (mg/kg) intravenously once every 4 weeks (q4wks) as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.03mg/kg
n=3 participants at risk
Participants received PF-05082566 0.03mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.06mg/kg
n=6 participants at risk
Participants received PF-05082566 0.06mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.12mg/kg
n=4 participants at risk
Participants received PF-05082566 0.12mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.18mg/kg
n=3 participants at risk
Participants received PF-05082566 0.18mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.24mg/kg
n=42 participants at risk
Participants received PF-05082566 0.24mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.3mg/kg
n=3 participants at risk
Participants received PF-05082566 0.3mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 0.6mg/kg
n=4 participants at risk
Participants received PF-05082566 0.6mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 1.2mg/kg
n=31 participants at risk
Participants received PF-05082566 1.2mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 2.4mg/kg
n=5 participants at risk
Participants received PF-05082566 2.4mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 5mg/kg
n=6 participants at risk
Participants received PF-05082566 5mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion A: PF-05082566 10mg/kg
n=11 participants at risk
Participants received PF-05082566 10mg/kg intravenously q4wks as a single agent in Portion A, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.03mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.03mg/kg intravenously q4wks in combination with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.06mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.06mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.12mg/kg + Rituximab 375mg/m^2
n=4 participants at risk
Participants received PF-05082566 0.12mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.18mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.18mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.24mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.24mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.3mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 0.3mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 0.6mg/kg + Rituximab 375mg/m^2
n=4 participants at risk
Participants received PF-05082566 0.6mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 1.2mg/kg + Rituximab 375mg/m^2
n=32 participants at risk
Participants received PF-05082566 1.2mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 2.4mg/kg + Rituximab 375mg/m^2
n=3 participants at risk
Participants received PF-05082566 2.4mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 5mg/kg + Rituximab 375mg/m^2
n=5 participants at risk
Participants received PF-05082566 5mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
Portion B: PF-05082566 10mg/kg + Rituximab 375mg/m^2
n=4 participants at risk
Participants received PF-05082566 10mg/kg intravenously q4wks in combination with rituximab (375mg/m\^2 intravenously, every week during the first 4 weeks) in Portion B, for up to 2 years or until participant permanently discontinued study treatment, whichever occurred earlier.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.5%
4/42 • Number of events 6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.1%
5/31 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
3/42 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.1%
5/31 • Number of events 7 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
3/42 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.9%
4/31 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.5%
4/42 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
19.4%
6/31 • Number of events 8 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • Number of events 8 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
21.4%
9/42 • Number of events 10 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
32.3%
10/31 • Number of events 11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
3/42 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.9%
4/31 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Axillary pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest pain
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chills
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Device related thrombosis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Drug withdrawal syndrome
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
42.9%
18/42 • Number of events 19 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.8%
8/31 • Number of events 10 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
75.0%
3/4 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.8%
6/32 • Number of events 7 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Implant site erythema
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Non-cardiac chest pain
|
25.0%
1/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.7%
3/31 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Peripheral swelling
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
21.4%
9/42 • Number of events 11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
15.6%
5/32 • Number of events 6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.5%
4/42 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
19.4%
6/31 • Number of events 7 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
3/42 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
3/42 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
12.5%
4/32 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.9%
5/42 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
18.8%
6/32 • Number of events 8 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.8%
2/42 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.5%
4/42 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.7%
3/31 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.9%
5/42 • Number of events 6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
40.0%
2/5 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
3/42 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urinary hesitation
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.5%
4/42 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
21.9%
7/32 • Number of events 7 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
14.3%
6/42 • Number of events 6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.5%
2/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
25.0%
1/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.2%
1/31 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.7%
3/31 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.1%
3/42 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.4%
1/42 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Diplopia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Orbital oedema
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Early satiety
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Infusion site oedema
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Feeling hot
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Induration
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Injection site pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Mucosal dryness
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Nodule
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
66.7%
2/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
8/32 • Number of events 10 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
15.6%
5/32 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 8 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 7 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
50.0%
2/4 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
9.4%
3/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
2/32 • Number of events 2 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.1%
1/32 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Seborrhoea
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
33.3%
1/3 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/42 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/31 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
25.0%
1/4 • Number of events 1 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/32 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/3 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/4 • Up to approximately 4 years.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER