Trial Outcomes & Findings for A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer (NCT NCT00510718)
NCT ID: NCT00510718
Last Updated: 2019-10-03
Results Overview
An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
140 participants
Primary outcome timeframe
Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Results posted on
2019-10-03
Participant Flow
Participant milestones
| Measure |
MDV3100 (Enzalutamide): No Previous Chemotherapy
Participants with no prior exposure to chemotherapy received single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 milligram per day (mg/day) dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the maximum tolerated dose (MTD) was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, dose limiting toxicity (DLT) or disease progression occurred. Participants were followed up for 30 days after last dose of study drug for safety follow up.
|
MDV3100 (Enzalutamide): Post Chemotherapy
Participants with prior exposure to chemotherapy single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 mg/day dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the MTD was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period, for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, DLT or disease progression occurred. Participants were followed up for 30 days after last dose.
|
|---|---|---|
|
Single Dose Period: 1 Week
STARTED
|
15
|
12
|
|
Single Dose Period: 1 Week
30 mg/Day
|
3
|
0
|
|
Single Dose Period: 1 Week
60 mg/Day
|
3
|
0
|
|
Single Dose Period: 1 Week
150/160 mg/Day
|
2
|
1
|
|
Single Dose Period: 1 Week
240 mg/Day
|
3
|
0
|
|
Single Dose Period: 1 Week
360 mg/Day
|
4
|
2
|
|
Single Dose Period: 1 Week
480 mg/Day
|
0
|
6
|
|
Single Dose Period: 1 Week
600 mg/Day
|
0
|
3
|
|
Single Dose Period: 1 Week
COMPLETED
|
15
|
12
|
|
Single Dose Period: 1 Week
NOT COMPLETED
|
0
|
0
|
|
Multiple Dose Period: 12 Weeks
STARTED
|
65
|
75
|
|
Multiple Dose Period: 12 Weeks
30 mg/Day
|
3
|
0
|
|
Multiple Dose Period: 12 Weeks
60 mg/Day
|
15
|
12
|
|
Multiple Dose Period: 12 Weeks
150/160 mg/Day
|
15
|
13
|
|
Multiple Dose Period: 12 Weeks
240 mg/Day
|
17
|
12
|
|
Multiple Dose Period: 12 Weeks
360 mg/Day
|
15
|
13
|
|
Multiple Dose Period: 12 Weeks
480 mg/Day
|
0
|
22
|
|
Multiple Dose Period: 12 Weeks
600 mg/Day
|
0
|
3
|
|
Multiple Dose Period: 12 Weeks
COMPLETED
|
50
|
43
|
|
Multiple Dose Period: 12 Weeks
NOT COMPLETED
|
15
|
32
|
Reasons for withdrawal
| Measure |
MDV3100 (Enzalutamide): No Previous Chemotherapy
Participants with no prior exposure to chemotherapy received single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 milligram per day (mg/day) dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the maximum tolerated dose (MTD) was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, dose limiting toxicity (DLT) or disease progression occurred. Participants were followed up for 30 days after last dose of study drug for safety follow up.
|
MDV3100 (Enzalutamide): Post Chemotherapy
Participants with prior exposure to chemotherapy single oral dose of MDV3100 in 1 out of the 7 cohorts of 30, 60, 150, 240, 360, 480 or 600 mg/day dose on Day 1 and were followed up for 6 days in single dose (dose escalation) period. Dose escalation from 30 to 600 mg/day continued until the MTD was determined or until a dose of 600 mg/day was evaluated. After dose-escalation, the cohorts receiving 60-600 mg/day dose were expanded in multiple dose (dose expansion) period, where participants received MDV3100 according to their dose in single dose period, for 84 days. This was followed by long-term dosing period in which participants continued to receive 160 mg/day dose of MDV3100 until withdrew of consent, DLT or disease progression occurred. Participants were followed up for 30 days after last dose.
|
|---|---|---|
|
Multiple Dose Period: 12 Weeks
Adverse Event
|
1
|
8
|
|
Multiple Dose Period: 12 Weeks
PSA Disease Progression
|
3
|
6
|
|
Multiple Dose Period: 12 Weeks
Radiologic Disease Progression
|
8
|
11
|
|
Multiple Dose Period: 12 Weeks
Clinical Disease Progression
|
1
|
3
|
|
Multiple Dose Period: 12 Weeks
Withdrawal by Subject
|
1
|
3
|
|
Multiple Dose Period: 12 Weeks
Other
|
1
|
1
|
Baseline Characteristics
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
Baseline characteristics by cohort
| Measure |
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=27 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=28 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=28 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 480 mg /Day
n=22 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
Total
n=140 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
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
54 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
86 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
140 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
134 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
135 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)Population: Safety population included all enrolled participants who received at least 1 dose of study drug.
An adverse events (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=22 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=27 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=28 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=28 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
n=18 Participants
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (SAEs)
|
1 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
14 Participants
|
8 Participants
|
6 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to first 35 days of the study treatment in multiple dose periodPopulation: Safety population included all enrolled participants who received at least 1 dose of study drug.
DLT was defined as a national cancer institute's common toxicity criteria for adverse events (NCI-CTCAE) version 3.0 grade 3 or greater toxicity regardless of perceived causality that is not improved by the use of adequate/maximal medical intervention. Grade 3 alopecia, fever without neutropenia, nausea, vomiting, fatigue, and self-limited or medically controllable adverse events were not considered as DLTs.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=22 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=27 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=28 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=28 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least 1 Dose-limiting Toxicity (DLT): Multiple Dose Period
|
1 percentage of participants
|
2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
1 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to first 35 days of the study treatment in multiple dose periodPopulation: Safety population included all enrolled participants who received at least 1 dose of study drug.
Tolerability was defined as if less than (\<) 4/12 in participants with no prior exposure to MDV3100 (chemo-naive) and \< 4/12 prior chemotherapy participants experienced a DLT within the first 35 days of the multiple dose period. For doses higher than 360 mg/day, tolerability was defined if \<8/24 participants previously treated with chemotherapy experience a DLT within the first 35 days of the multiple dose period. MTD was defined as a dose below the intolerable dose.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=140 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of MDV3100: Multiple Dose Period
|
—
|
—
|
240 milligrams per day
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post dose on Day 1 of Single Dose PeriodPopulation: Pharmacokinetic (PK) evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=3 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=3 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=3 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=6 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Single Dose Period
|
—
|
—
|
5.43 microgram*hour per milliliter
Geometric Coefficient of Variation 11.80
|
15.64 microgram*hour per milliliter
Geometric Coefficient of Variation 3.50
|
38.21 microgram*hour per milliliter
Geometric Coefficient of Variation 23.64
|
58.39 microgram*hour per milliliter
Geometric Coefficient of Variation 47.64
|
79.26 microgram*hour per milliliter
Geometric Coefficient of Variation 19.29
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours postdose on Day 1 of Single Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=4 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=3 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=3 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=3 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=3 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-t]) of MDV3100: Single Dose Period
|
363.4 microgram*hour per milliliter
Geometric Coefficient of Variation 38.7
|
391.9 microgram*hour per milliliter
Geometric Coefficient of Variation 14.0
|
21.2 microgram*hour per milliliter
Geometric Coefficient of Variation 14.2
|
53.1 microgram*hour per milliliter
Geometric Coefficient of Variation 4.1
|
145.3 microgram*hour per milliliter
Geometric Coefficient of Variation 10.0
|
208.5 microgram*hour per milliliter
Geometric Coefficient of Variation 44.0
|
320.2 microgram*hour per milliliter
Geometric Coefficient of Variation 12.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=4 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=3 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=3 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=3 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=5 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of MDV3100: Single Dose Period
|
952.7 microgram*hour per milliliter
Geometric Coefficient of Variation 42.4
|
865.0 microgram*hour per milliliter
Geometric Coefficient of Variation 34.6
|
51.3 microgram*hour per milliliter
Geometric Coefficient of Variation 39.8
|
92.7 microgram*hour per milliliter
Geometric Coefficient of Variation 19.0
|
331.5 microgram*hour per milliliter
Geometric Coefficient of Variation 14.6
|
459.2 microgram*hour per milliliter
Geometric Coefficient of Variation 32.7
|
706.7 microgram*hour per milliliter
Geometric Coefficient of Variation 17.7
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=6 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=3 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=3 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=3 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=6 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Single Dose Period
|
1.54 hours
Interval 0.53 to 2.08
|
1.03 hours
Interval 1.03 to 2.0
|
1.98 hours
Interval 0.42 to 4.0
|
0.50 hours
Interval 0.48 to 1.0
|
0.53 hours
Interval 0.5 to 1.98
|
1.00 hours
Interval 0.57 to 1.0
|
1.03 hours
Interval 0.53 to 2.2
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=6 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=3 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=3 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=3 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=6 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MDV3100: Single Dose Period
|
5.93 microgram per milliliter
Geometric Coefficient of Variation 66.03
|
5.17 microgram per milliliter
Geometric Coefficient of Variation 19.51
|
0.43 microgram per milliliter
Geometric Coefficient of Variation 15.97
|
1.65 microgram per milliliter
Geometric Coefficient of Variation 28.77
|
3.30 microgram per milliliter
Geometric Coefficient of Variation 22.85
|
5.19 microgram per milliliter
Geometric Coefficient of Variation 18.64
|
6.68 microgram per milliliter
Geometric Coefficient of Variation 39.61
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
T 1/2 is the time measured for the plasma concentration of MDV3100 to decrease by one half.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=4 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=3 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=3 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=3 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=5 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Elimination Half-Life (T1/2) of MDV3100: Single Dose Period
|
144.0 hours
Standard Deviation 68.4
|
130.4 hours
Standard Deviation 37.7
|
164.9 hours
Standard Deviation 69.8
|
100.5 hours
Standard Deviation 30.9
|
143.7 hours
Standard Deviation 34.8
|
138.9 hours
Standard Deviation 22.6
|
149.1 hours
Standard Deviation 26.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Volume of distribution is defined as the theoretical volume in which the total amount of MDV3100 would need to be uniformly distributed to produce the desired plasma concentration of MDV3100. Apparent volume of distribution after oral dose (V/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=4 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=3 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=3 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=3 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=5 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (V/F) of MDV3100: Single Dose Period
|
97.4 liters
Geometric Coefficient of Variation 30.7
|
126.4 liters
Geometric Coefficient of Variation 8.8
|
131.7 liters
Geometric Coefficient of Variation 15.6
|
90.5 liters
Geometric Coefficient of Variation 16.0
|
91.89 liters
Geometric Coefficient of Variation 13.31
|
103.8 liters
Geometric Coefficient of Variation 48.5
|
108.2 liters
Geometric Coefficient of Variation 15.8
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4, 6, 24, 48, 72, 96, 120 hours post dose on Day 1 of Single Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=4 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=3 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=3 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=3 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=5 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance (CL/F) of MDV3100: Single Dose Period
|
0.504 liters per hour
Geometric Coefficient of Variation 42.437
|
0.694 liters per hour
Geometric Coefficient of Variation 34.625
|
0.585 liters per hour
Geometric Coefficient of Variation 39.810
|
0.647 liters per hour
Geometric Coefficient of Variation 18.988
|
0.453 liters per hour
Geometric Coefficient of Variation 14.583
|
0.523 liters per hour
Geometric Coefficient of Variation 32.679
|
0.509 liters per hour
Geometric Coefficient of Variation 17.711
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=1 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=20 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=22 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=14 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC[0-24]) of MDV3100: Multiple Dose Period
|
463.1 microgram*hour per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
—
|
60.0 microgram*hour per milliliter
Geometric Coefficient of Variation 21.0
|
109.8 microgram*hour per milliliter
Geometric Coefficient of Variation 34.4
|
291.7 microgram*hour per milliliter
Geometric Coefficient of Variation 24.9
|
395.7 microgram*hour per milliliter
Geometric Coefficient of Variation 27.4
|
488.9 microgram*hour per milliliter
Geometric Coefficient of Variation 23.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=1 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=21 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=23 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=16 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of MDV3100: Multiple Dose Period
|
0.00 hours
Interval 0.0 to 0.0
|
—
|
2.07 hours
Interval 1.0 to 3.92
|
1.07 hours
Interval 0.5 to 23.67
|
1.00 hours
Interval 0.0 to 25.8
|
1.08 hours
Interval 0.0 to 26.17
|
1.57 hours
Interval 0.48 to 24.08
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=1 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=21 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=23 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=16 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of MDV3100: Multiple Dose Period
|
27.90 microgram per milliliter
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only 1 participant was analyzed.
|
—
|
2.76 microgram per milliliter
Geometric Coefficient of Variation 21.10
|
5.49 microgram per milliliter
Geometric Coefficient of Variation 28.88
|
14.07 microgram per milliliter
Geometric Coefficient of Variation 25.36
|
18.91 microgram per milliliter
Geometric Coefficient of Variation 26.57
|
24.57 microgram per milliliter
Geometric Coefficient of Variation 21.00
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Multiple Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=16 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 Participants
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=22 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=24 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=25 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=21 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Minimum Observed Plasma Concentration (Cmin) of MDV3100: Multiple Dose Period
|
0.00 microgram per milliliter
Standard Deviation 0.00
|
1.89 microgram per milliliter
Standard Deviation 0.55
|
0.10 microgram per milliliter
Standard Deviation 0.03
|
0.00 microgram per milliliter
Standard Deviation 0.00
|
0.04 microgram per milliliter
Standard Deviation 0.19
|
0.00 microgram per milliliter
Standard Deviation 0.00
|
0.00 microgram per milliliter
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 24 hours post dose on Day 84 of Multiple Dose PeriodPopulation: PK evaluable population: all participants who received study drug and had sufficient PK samples for calculation of at least 1 MDV3100 PK parameter. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
Clearance of a MDV3100 is a measure of the rate at which a MDV3100 is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=1 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=20 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=22 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=14 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance (CL/F) of MDV3100: Multiple Dose Period
|
1.037 liters per hour
Standard Deviation NA
Standard deviation could not be estimated as only 1 participant was analyzed.
|
—
|
0.507 liters per hour
Standard Deviation 0.111
|
0.580 liters per hour
Standard Deviation 0.245
|
0.530 liters per hour
Standard Deviation 0.149
|
0.628 liters per hour
Standard Deviation 0.179
|
0.755 liters per hour
Standard Deviation 0.176
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 84Population: Analysis population included all enrolled participants who received at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Prostate-specific antigen is a glycoprotein considered as a biomarker for the response to therapy in men with prostate cancer. A 50 percent (%) decline in PSA from baseline to the PSA level at Day 84 was considered as a PSA response.
Outcome measures
| Measure |
MDV3100 (Enzalutamide) 480 mg /Day
n=11 Participants
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 30 mg/Day
n=3 Participants
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=24 Participants
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=24 Participants
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=20 Participants
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=21 Participants
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Prostate Specific Antigen (PSA) Response at Day 84: Multiple Dose Period
|
45.5 percentage of participants
Interval 16.7 to 76.6
|
—
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
50.0 percentage of participants
Interval 29.1 to 70.9
|
66.7 percentage of participants
Interval 44.7 to 84.4
|
75.0 percentage of participants
Interval 50.9 to 91.3
|
71.4 percentage of participants
Interval 47.8 to 88.7
|
—
|
Adverse Events
MDV3100 (Enzalutamide) 30 mg/Day
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MDV3100 (Enzalutamide) 60 mg /Day
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
MDV3100 (Enzalutamide) 150/160 mg/Day
Serious events: 14 serious events
Other events: 27 other events
Deaths: 0 deaths
MDV3100 (Enzalutamide) 240 mg /Day
Serious events: 8 serious events
Other events: 29 other events
Deaths: 0 deaths
MDV3100 (Enzalutamide) 360 mg /Day
Serious events: 6 serious events
Other events: 28 other events
Deaths: 0 deaths
MDV3100 (Enzalutamide) 480 mg /Day
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
MDV3100 (Enzalutamide) 600 mg /Day
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
Serious events: 10 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MDV3100 (Enzalutamide) 30 mg/Day
n=3 participants at risk
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=27 participants at risk
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=28 participants at risk
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 participants at risk
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=28 participants at risk
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 480 mg /Day
n=22 participants at risk
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 participants at risk
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
n=18 participants at risk
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
MDV3100 (Enzalutamide) 30 mg/Day
n=3 participants at risk
Participants received 30 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 60 mg /Day
n=27 participants at risk
Participants received 60 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 150/160 mg/Day
n=28 participants at risk
Participants who received 150 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period. This dose was then changed subsequently to 160 mg/day according to Protocol amendment. Participants continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 240 mg /Day
n=29 participants at risk
Participants received 240 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 360 mg /Day
n=28 participants at risk
Participants received 360 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 480 mg /Day
n=22 participants at risk
Participants received 480 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 600 mg /Day
n=3 participants at risk
Participants received 600 mg of Enzalutamide on Day 1 and were followed for 6 days in single dose period and continued to receive the same dose in multiple dose period for 84 days.
|
MDV3100 (Enzalutamide) 160 mg /Day: Long Term Dosing Period
n=18 participants at risk
All participants after multiple dose period, continued to receive 160 mg/day oral dose of Enzalutamide in long term dosing period until they voluntarily withdrew, experienced a DLT or were diagnosed with disease progression.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.5%
5/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.8%
4/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
37.0%
10/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
8/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
24.1%
7/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
39.3%
11/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
27.3%
6/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
6/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
25.9%
7/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
8/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
40.9%
9/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
44.4%
8/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.5%
5/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.2%
5/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Facial pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
63.0%
17/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
67.9%
19/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
69.0%
20/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
82.1%
23/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
72.7%
16/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
72.2%
13/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Irritability
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Local swelling
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Mass
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal dryness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Nodule
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
6/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
32.1%
9/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.2%
5/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
16.7%
3/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Sluggishness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Thirst
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Axillary candidiasis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Blastocystis infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Eye infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.8%
4/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
16.7%
3/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Medical device pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood calcium increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood potassium increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Bone density decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Cardiac murmur
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Heart rate irregular
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Immunoglobulins increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Light chain analysis increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Occult blood positive
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
6/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.6%
3/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
6/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
8/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.8%
4/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
32.1%
9/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
6/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.2%
5/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
40.7%
11/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
8/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
24.1%
7/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
8/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.7%
5/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
44.4%
8/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
40.7%
11/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
27.6%
8/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
32.1%
9/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
27.3%
6/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
27.8%
5/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.2%
5/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.6%
3/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
9/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.2%
5/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
4/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
9/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
31.0%
9/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.6%
3/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
4/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
25.0%
7/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.2%
5/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
25.0%
7/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
28.6%
8/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.6%
3/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
6/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
20.7%
6/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.7%
5/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Judgement impaired
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.6%
3/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Mental retardation severity unspecified
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.3%
3/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
27.8%
5/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Speech disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Vertigo positional
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.6%
3/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.7%
5/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.2%
4/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Impatience
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.5%
5/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Phobia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.8%
4/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
16.7%
3/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
18.5%
5/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
16.7%
3/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
6/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urine abnormality
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Genital erythema
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
6/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
24.1%
7/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
38.9%
7/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
9/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
25.0%
7/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
34.5%
10/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.6%
3/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
27.8%
5/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hair growth abnormal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.3%
4/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
14.8%
4/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
13.8%
4/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hot flush
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
25.9%
7/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
25.0%
7/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
21.4%
6/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
10.7%
3/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
9.1%
2/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Atrophy
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Cyst
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site nodule
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Ear infection staphylococcal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
4/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
3/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
11.1%
2/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Balanitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Schamberg's disease
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
5.6%
1/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Congenital, familial and genetic disorders
Spondylolisthesis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Ectropion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eye swelling
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Glare
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Ocular icterus
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Refraction disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Visual disturbance
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
17.9%
5/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faecal volume decreased
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.1%
2/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
7.4%
2/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip exfoliation
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
6.9%
2/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
22.2%
6/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
39.3%
11/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
20.7%
6/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
67.9%
19/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
50.0%
11/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oral soft tissue disorder
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pruritus ani
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.7%
1/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
4.5%
1/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/27 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.6%
1/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
3.4%
1/29 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/28 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/22 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/3 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
0.00%
0/18 • Baseline up to 30 days after last dose of study treatment (approximately maximum of 129 months)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have experienced both SAE and NSAE. Analysis population included all enrolled participants who received at least 1 dose of study drug.
|
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